Director of Regulatory Affairs

  •  

Boston, MA

Industry: Manufacturing

  •  

11 - 15 years

Posted 25 days ago

  by    Randy Edwards

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 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 (MSpreferred)
  • 10 + years Regulatory Affairsexperience 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 contact information in a header

Please tell us:

Where do you currently reside?

Will you relocate? Yes/No

Are you a US citizen? 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

Edwards Place of Employment is a BBB accredited business