STAFF REGULATORY AFFAIRS SPECIALIST

Durham, NC 27711

Post Date: 03/08/2018 Job ID: 281204-0_1 Category: Pharmaceutical Salary: $115000
STAFF REGULATORY AFFAIRS SPECIALIST
Industry: Medical Equipment / Devices
Category: Legal - Regulatory / Compliance Law
Location: Durham, NC

Description Overview
1.Staff Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderate to highly complex submissions to US FDA and/or international regulatory agencies;
2.Providing risk assessments of strategies and regulatory options to business teams and to product development/support teams
3.Executing regulatory product submissions, from the strategic planning stages through conduct/completion of clinical trials, submission to regulatory agencies and post-market activities, as required
4.Exercising considerable latitude in determining the manner in which to most efficiently organize activities to complete these submissions.

Qualifications:
1.B.S. degree or higher in scientific field or equivalent regulatory/scientific experience.
2.Advanced degree and/or RAC certification preferred.
3.Minimum 5-8 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).
4.Working knowledge of medical device and/or in vitro diagnostic device regulations, 510(k) and/or Premarket Approval (PMA) process.
5.Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
6.Demonstrated success preparing, filing and completing (including internal and external negotiations) regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation).
7.Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
8.Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
9.Experience analyzing complex issues and formulating cogent approaches to resolving/addressing issues.
10.Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
11.Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
12.Experience maintaining confidential information at appropriate levels within an organization.

Preferred Qualities:
1.Experience with in vitro diagnostic devices.
2.Experience with US FDA Class III medical device and/or in vitro diagnostic device submissions (PMA, PMAS, Annual Reports).
3.Experience working directly with FDA, notified bodies and/or international health authorities.
4.B.S. degree or higher in scientific field or equivalent regulatory/scientific experience.
5.Advanced degree and/or RAC certification preferred.
6.Minimum 5-8 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s).
7.Working knowledge of medical device and/or in vitro diagnostic device regulations, 510(k) and/or Premarket Approval (PMA) process.
8.Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
9.Demonstrated success preparing, filing and completing (including internal and external negotiations) regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation).

Details:
1.Security Clearance Not Required
2.Visa Candidates Not Considered
3.Competitive Base Salary
4.Full-time Benefits
5.Relocation Assistance Available For Ideal Candidate
6.Not Overtime Eligible
7.Interview Travel Not Reimbursed
8.5+ to 8 years of experience
9.Minimum Education - Bachelor's Degree
10.Willingness to Travel Occasionally

Responsibilities:
1.Manages planning and preparation of regulatory submissions (510(k), PMA, PMAS, Technical Files and other regulatory documentation) for produc

Ken Kupersmith
Executive Recruiter

Ken's relationship with his clients and candidates is one of personalized, knowledgeable service. His primary focus is helping companies acquire the top talent they need to grow, and working with candidates throughout their careers to put their skills to their highest and best use.Ken's practice focus is in the recruitment of Medical Affairs, MSLs, Regulatory Affairs and Medical and Scientific Writers.
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