Director of Regulatory Affairs MB347

Boston, MA AREA

Competitive Salary + Bonus

Relo: No, Must live in the area

Our client company has developed an innovative new product and is seeking an experienced director level professional to be responsible for developing and managing the regulatory strategy for current and future products.

You must be willing to:
Develop/prepare/execute/manage high quality regulatory strategy/filings/communications for medical devices
Provide guidance/develop/oversee strategy to support approved/planned products
Identify additional commercial opportunities
Develop/manage/interact with domestic/international regulatory authority personnel/consultants/vendors
Represent the companys regulatory function at regulatory body meetings

Requirements (IF YOU DONT HAVE THESE, DONT APPLY)
BS in Biology/Chemistry/Biomedical Engineering or relevant field (MS preferred)
10 + years Regulatory Affairs experience with medical or technology devices in a regulated industry.
Prior PMA submission experience
Proven track record of success leading products through regulatory approval
Strong budgeting/problem solving/organizational/planning/analytical skills

Our client requests resumes be submitted in Word Doc format, '97-2003, without headers.

Please tell us:
Where do you currently reside?
Will you relocate? Yes/No
Current salary?/Desired salary?

Full Time, Permanent Position

Must be authorized to work in the United States without company sponsorship needed now or future

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