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