Jobs Posted through July 4, 2008 - Audrey' s Network
Jobs That Crossed My Desk Through July 26, 2009
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
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Jay Feeley, National Account Manager
The Medical, Life Sciences & Biotech Group
My Profile: Jay Feeley
Mailto: jfeeley@
Management Recruiters of Baltimore-Timonium
Website:
Phone: 443 921-9069 direct - 410 252-6616 x224 - 866 277-4049 toll freeMy name is Jay Feeley, and I am a National Executive Recruiter specializing in the Medical Device Arena. I am currently recruiting for a RA Program Director, and RA Program Manager, and a Sr. Quality Engineer for a very well established medical device company specializing in class III Vascular/Cardiac devices and disposables.
Location: Arizona (Relocation assistance available)
Must-Haves to Interview
RA Program Director
-Bach degree in life or eng science
-10 RA exp, min
-7 in mgr role
-comprehensive knowledge of US, European, and int'l regulations and standards (class III PMA. class II 510K) *** Must have experience writing and submitting PMA’s and 510K’s.
___________________________________________________________________________________
RA Program Manager
-Bach degree in life or eng science
-6-8 yrs RA exp, min 3 in mgr role
-comprehensive knowledge of US, European, and int'l regulations and standards (PMA. 510K)
_____________________________________________________________________________________
Sr. Quality Engineer
-BS + 7 yrs or Masters
-+ 3 yrs med device exp, new product development a must, extensive knowledge of FDA, GMP/GLP, ISO, ASTM, AAMI, CEN, -ASQ (Quality Eng Cert) or equivalent
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If this isn’t the right fit for you and you know someone that I should be talking to, please pass this along. Also, if you know anyone you could refer, even just to network with, it would be greatly appreciated.
If you have interest in this position and would like more in depth information about this position, please respond with an updated resume and the best time to for you and I to talk further.
Also I am happy to confidentially discuss other career opportunities in the medical device field if this is not the best fit or location for you. Please just respond with a resume and/or the best time to talk.
Thank you for your time and have a great day!
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Qualified candidates please reply to:
Christina Lehrman
clehrman@
tel: 925-242-1010 x 104
Below is our update on the med device positions we are currently working on. We have positions in the SF bay area as well as other locations across the country. You are welcome to pass this along to anyone that may be interested. If you have any questions, please feel free to get in touch anytime. Also, you may review the detailed job descriptions posted on our site at .
Most Urgent Positions:
▪ Director of Regulatory Affairs (SF Bay Area)
▪ Director of Regulatory Affairs (NM)
▪ Sr. Product Marketing Manager
▪ Principal International Regulatory Affairs Specialist
REGULATORY, QUALITY & CLINICAL AFFAIRS
Regulatory Affairs Director (SF Bay Area)
▪ Minimum of 7+ years experience in US and OUS medical device Regulatory Affairs management and execution
▪ Strong knowledge of IDE, PMA, 510(k), ISO, and QSR requirements required
▪ Experience with PMA supplements and manufacturing changes
▪ Bachelors Degree in scientific or health related field
_________________________________________________
Regulatory Affairs Director (NM)
▪ 10+ years of medical device experience
▪ PMA experience required
▪ Experience working with the OIVD at the FDA is a requirement
▪ Bachelors Degree in scientific or health related field
_________________________________________________
Principal International Regulatory Affairs Specialist
▪ Minimum of 5 years experience in US and OUS class III medical device Regulatory Affairs management and execution
▪ Strong knowledge of IDE, PMA, 510(k), ISO, and QSR requirements required
▪ Working knowledge of US and OUS clinical research regulations and techniques
▪ Demonstrated ability to effectively implement and manage complex global regulatory program
▪ Bachelors Degree in scientific or health related field required
_______________________________________________
Sr. Global Regulatory Affairs Director (S. CA)
▪ Minimum of 10+ years experience in US and OUS medical device Regulatory Affairs management and execution
▪ Emphasis is on international RA management
▪ Strong management skills, at least 3 yrs of senior management experience
▪ Bachelors Degree in scientific or health related field
___________________________________________________________
Sr. Regulatory Affairs Specialist (S. CA)
▪ At least 5 years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, MHLW, TGA, and TPP
▪ 510(k), IDE and PMA experience (desired)
▪ Knowledge of FDA, EU, MHLW, TGA, and TPP requirements
▪ Bachelor’s degree in related field
Regulatory Affairs Certification (desired)
▪ ______________________________________________________________
R&D, MANUFACTURING & OPERATIONS ROLES
(Senior) Manufacturing Engineer (S. CA)
♣ BS degree in Mechanical or Materials Engineering is required. 3+ yrs med device experience.
♣ Knowledge of mechanics of materials and strong problem solving skills.
♣ ISO/GMP training and project management/leadership skills a strong plus.
▪ Experience with statistical and analytical methods and strong mechanical design skills including test methods and test-fixture design required.
_________________________________________________________
Process Development Manufacturing Engineer (S. CA)
▪ BS degree in Mechanical or Materials Engineering is required
▪ A minimum of three years of experience
▪ Knowledge of mechanics of materials and strong problem solving skills
▪ ISO/GMP training and project management/leadership skills a strong plus
▪ Experience with statistical and analytical methods and strong mechanical design skills including test methods and test-fixture design required.
______________________________________________________________
Process Development Manufacturing Engineering Manager (S. CA)
▪ BS degree in Mechanical or Materials Engineering is required
▪ A minimum of 5 years of manufacturing exp in medical device industry
▪ Strong management skills
▪ ISO/GMP training and project management/leadership skills a strong plus
▪ Experience with statistical and analytical methods and strong mechanical design skills including test methods and test-fixture design required.
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SALES, MARKETING & BUSINESS DEVELOPMENT
Sr. Product Marketing Manager
▪ OR experience is required (laparoscopic/endoscopic device experience would be a major plus)
▪ 5+ yrs med device marketing experience
▪ BA,BS degree
▪ Strong downstream marketing experience is a requirement
▪ Travel 30%+
______________________________________________________________
Director of Marketing
▪ Strong background in DTC/DTP (direct to consumer/patient) marketing experience
▪ 4+ yrs experience in Product Management
▪ Consultant and Ad Agency experience
▪ Sleep medicine or pulmonary device experience is a plus
▪ Travel 30% - 40%
_____________________________________________________
Clinical Specialist - CRM (location would be in FL)
▪ BA/BS
▪ 3 - 4+ yrs experience as clinical specialist in medical device industry
▪ Cardiac rhythm management device experience
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Please contact Cheryl Heinla if interested. Her email address is
Cheryl.Heinla@.
*
1)Food Science - Research for 3 months temporary. Must have
Research/Formulations experience. (I.e. someone with only QC will not
be considered). Hayward.
2) Jr. Mechanical Engineer - Biotech - rapid diagnostics. Prototyping,
machining, some electronic work. Hayward. Temp to hire.
3) Documentation for pharmaceutical. Must have excellent writing skills.
Location is Hollister. Temp 6 months.
4) Research Asst. in DMPK. 1-3 yrs. exp. with HPLC, LC/MS, other
molecular techniques. South SF. Temp 6 months.
5) Research Assoc for small molecule resuspending. Molecular biology
techniques. South SF. Temp 6 months.
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If you or someone you know is interest please contact Muara directly at:
Maura E. Markowitz, CSAM, National Account Manager
The Engineering & Manufacturing Group
My Profile: Maura Markowitz
Mailto: mmarkowitz@
Management Recruiters of Baltimore-Timonium
Website:
Phone: 443 921-9051 direct - 410 252-6616 x285 - 866 277-4049 toll free
I am currently recruiting for an RA Program Director and an RA Program Manager for a medical device company specializing in vascular, urology and medical device disposables.
Location:
Tempe, AZ (relocation assistance is available)
Position Description (RA Program Director):
Manages the Regulatory Affairs department while also participating on project teams as the Regulatory Affairs core team member.
Responsible for the supervision of a regulatory submissions group, the development of a regulatory strategy on new medical devices, and high-level supervision of the preparation and submission of the Food and Drug Administration (FDA) submission packages in an accurate and timely manner including, but not limited to: 510(k)’s, IDE’s, and PMA’s. Also responsible for managing, developing, coaching and mentoring direct reports.
Requirements:
§ Bachelor’s Degree in life Science or Engineering
§ 10 years Regulatory Affairs Experience
§ 7 years in a management level role
§ Comprehensive know of US, European, and int'l regulations and standards (class III PMA. class II 510K)
Position Description (RA Program Manager):
This position manages the domestic (U.S.) and international activities of related product lines for the Regulatory Affairs department according to the company’s corporate procedures and policies; U.S. Government policies, primarily the Food and Drug Administration (FDA); applicable State requirements; and European and international regulations and standards.
This position coordinates domestic and international submission preparation and approval by the company, and FDA or appropriate international body in a timely manner. Responsible for determining RA strategies for relevant products. This position must recognize potential regulatory issues in day-to-day activities that involve product development through the manufacturing process.
Requirements:
§ Bachelor’s Degree in life Science or Engineering
§ 6+ years Regulatory Affairs Experience
§ 3 years in a management level role
§ Comprehensive know of US, European, and int'l regulations and standards (class III PMA. class II 510K)
If this isn't the right fit for you and you know someone that I should be talking to, please pass this along. Also, if you know anyone you could refer, even just to network with, it would be greatly appreciated.
If you have interest in this position and would like more in depth information about this position, please respond with an updated resume. Once I have had the opportunity to review your resume, I will be in touch to discuss this position in further detail.
Thank you for your time and have a great day
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To learn more about this position along with immediate attention
please call 813 321 1670 and send a copy of your resume attached as a
WORD document to: juang@.
My name is Juan Garcia. I represent The Fountain Group, which is a
Professional Contract Staffing Firm based out of Tampa, FL. We are
seeking qualified candidates to join our growing family of
professionals. We are currently seeking a Conformance Investigator for
a prominent client of ours in Berkeley, CA.
Contact recruiter if interested. It is a temporary position
Position description:
Purpose:
Senior technical professional who investigates and resolves complex
discrepancies in a timely manner. Leads multi-discipline teams to
determine root cause and identify effective corrective actions
Thoroughly understands manufacturing processes, procedures, equipment
and personnel expectations to evaluate discrepancies.
Resolves discrepancies that are site wide, cross process unit or
quality system issues
Tasks:
Influences direction of complex investigations and communicates with
all levels of employees
Recognized as an authority in multiple areas and provides leadership
and guidance to others
Exhibits leadership in conformance efforts
Innovative in identifying root causes and effective corrective actions
Coordinate and perform discrepancy investigations,
obtain/analyze/assess appropriate data/information, generate
appropriate written documentation to support rationale/justification
for decisions made regarding potential impact/risk and product
disposition
Administer the periodic review and evaluation of corrective actions to
determine effectiveness/patterns or recurring problems that suggest
the need for improvements
BS 8+ years
MS 6+ years
PhD 4+ years
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Contact Rod Pagan
Manufacturing Manager
Summary:
Manage the daily and long term objectives of the sterile filling and
packaging areas and manufacturing projects. Conduct departmental
operations in compliance with GMPs, SOPs and FDA guidelines. Assist
in the management of department personnel. Assume responsibility for
the GMP, environmental heath and safety procedure awareness, and
compliance within the respective area.
Duties:
Manage departmental employees; train, discipline, motivate, mentor and
develop in order to accomplish departmental goals within GMP/OSHA/SOP
and FDA guidelines. Manage the department within budgetary cost
savings constraints while meeting or exceeding internal and external
customer needs. Manage OEE, Material Variance, Schedule Attainment,
etc… Responsible for the job certification and training programs for
the department.
Manage departmental equipment, operations enhancement/improvements and
manufacturing projects. Manage attendance, scheduling and performance
appraisals for departmental associates. Involved in hiring process of
new associates.
Technical complaint investigations and failure investigations.
Participate on LEAN teams, review boards, in scheduling/performance
meetings and provide cross-departmental services. Implement and track
improvements.
Write, rewrite, amend documentation, protocols, reports and SOP’s.
Support LEAN initiatives. All other duties as assigned.
Education:
BS in Engineering, Chemistry, Biology or related field; Supervisory
and management courses recommended.
Experience:
5- 8 years in aseptic pharmaceutical filling and packaging.
Special Skills:
Strong communication and interpersonal skills, technical knowledge of
aseptic filling and packaging operations, extreme attention to detail,
time management ability, good organizational skills, flexible,
effective problem solver and solid leadership qualities. Ability to
write technical documents.
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Jay Feeley, National Account Manager
The Engineering and Manufacturing Group
Email: jfeeley@
Management Recruiters of Baltimore-Timonium
Website:
Phone: 443 921-9069 direct - 410 252-6616 x224 - 866 277-4049 toll free
Jay is currently recruiting for a Quality Systems Manager for a medical device company with facilities in 22 nations on six continents; the Company distributes its products in over 120 countries under some of the most well established brand names in the surgical device/disposables industry.
Location: Central, PA (Company will assist with Relocation)
Job Summary: This position will be responsible for managing the various aspects of the Quality and Management Systems including: CFR and ISO compliance, internal audits, complaint handling, corrective and preventive actions, document control, labeling control, complaint handling as well as process and software validation. The position will provide primary liaison to the rest of the company on regulatory matters.
Must-Haves to Interview
oBS technical/Life science degree
o3+yrs management exp at least 3 people
oexperience with improving performance issues & firing
o5+ yrs medical device experience-Class II or III
owork with cross functional teams
-Strong working knowledge of FDA 820 (QSR) and ISO 13485
- Working knowledge of CAPA, Complaint controls systems, risk management
- knowledge of basic submission-510k or PMA
-understanding labeling requirements a plus
-RA understanding (one or more) : understanding international submission, work with EU, involved in FDA audits, some type of response to FDA
If this isn't the right fit for you and you know someone that I should be talking to, please pass this along. Also, if you know anyone you could refer, even just to network with, it would be greatly appreciated.
If you have interest in this position and would like more in depth information about this position, please respond with an updated resume and the best time to for us to talk further.
Also I am happy to confidentially discuss other career opportunities in the medical device field if this is not the best fit or location for you. Please just respond with a resume and/or the best time to talk
__._,_.___
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Makro Technologies Job Alert
Biologist - I ()
Makro Scientific
Rahway, NJ
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Quality Complaint Handling Coordinator
Regulatory Regulatory Affairs Manager
Human Resources Director, Human Resources
What is Resume Inbox address?
hr@
access | closure
645 Clyde Avenue | Mountain View CA 94043
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Contact:
Charles Jo
Recruiter/Sourcer
Saratoga, CA 95070-1590
408.668.4220 cell | charlesj@
Biotech/Pharma | Medical Devices/Instrumentation | IT/Engineering/Web |
Social Ventures/Non-profits
Multiple job openings at Medicines360 (San Francisco, CA) a non-profit
pharma startup
MISSION
Medicines360's mission is to develop new, affordable and innovative
therapies to address health inequities, particularly for women and children
living in poverty in the U.S. and globally.
* Director Clinical Operations
* Clinical Trial
Manager
* Finance Manager
* Senior Executive
Assistant
Updated list at:
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Charles Jo is a in-house recruiter for Acclarent right now.
Acclarent is ramping up!! Please tell your group to go to their website and
if they are interested in a position they should send their resume to:
Charles Jo
Contract Recruiter
Acclarent
650.687.5404 ................
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