Director of Regulatory Affairs MB347
Boston, MA AREA
Salary: $130-$160K + 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 company’s regulatory function at regulatory body meetings
Requirements (IF YOU DON’T HAVE THESE, DON’T 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.
Full Time, Permanent Position
Must be authorized to work in the United States without company sponsorship needed now or future
Edwards Place of Employment is a BBB accredited business