Exponentially expanding high risk healthcare technology provider seeks an experienced Regulatory Affairs expert to lead a regulatory team submitting documents to the FDA demonstrating safety and effectiveness of Class III medical devices.

Shall:

*** Prepare global regulatory strategies for new high risk medical devices.

*** Lead the preparation and oversight of global regulatory filings including Pre Market Approval (PMAs) submissions for the FDA.

*** Support the regulatory team in providing recommendations, decisions, and feedback to product development.

*** Maintain awareness of international regulatory requirements for overseas registration and licensing of products.

*** Educate, train and guide Regulatory Affairs staff.

Qualifications:

*** Bachelor’s or Master’s degree in Engineering or Science.

*** Experience with successful PMA submission & approval for Class III medical devices.

Generous salary to $225,000 with competitive performance based bonus, full medical coverage and benefits including family dental, vision, prescription drugs, doctor visits, etc. Join a rapidly growing company in an emerging market with competitive 401(k) pension with dollar-for-dollar matching plan, non-monetary incentives, paid time off - including vacations, holidays, personal days, etc. - and more!

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000025327_10007337@jobbank302.com

Please reference #37083179 when responding.

5+ years

Massachusetts

$150,000.00

$225,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000025327_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Regulatory Affairs Director Head Medical Device FDA Food And Drug Administration Healthcare Technology Pre Market Approval PMA PMAs 510k 510(k) IDE Investigational Device Exemption HDE Humanitarian Device Exemption Regulations Regulatory Affairs Director Manufacturing In-Vivo Diagnostics IVD Reagents Class 3 Class III High Risk Medical Devices

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