A medical device manufacturing company located in southern Connecticut is looking for a Regulatory Affairs Specialist to join a new product development team. This is a well-established, cutting-edge company poised for high growth in the rapidly evolving spine products market segment. Total compensation includes salary, generous benefit package and relocation assistance.

Overall Position Description:

Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance to all US requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products. Participate in cross functional team activities from initial stages through securing government approvals.

Responsibilities

- Participate on product development teams to insure US regulatory requirements are incorporated as part of the development process. Author submissions and other regulatory documents to obtain approval to bring new or modified products to market

- Assist in post market submissions (progress reports, annual reports etc.). Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product

- Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues. Establish and maintain regulatory information systems both electronically and hard copy.

- Communicate any FDA correspondence on submissions to the appropriate team(s) and RA management.

- Labeling, marketing, product transfer and literature review pre and post market. Assist with post marketing surveillance and vigilance

Qualifications/Work Experience

- Preferred Minimum 4-6 year experience in FDA regulated Class II and Class III industry

- Minimum 6-8 years total work experience 510(k),IDE,PMA (original/revision/supplements) preparation

- Working knowledge of Medical Device Regulations (FDA required, international a plus). Direct interaction with FDA or Notified Bodies/Competent Authorities reviewers/inspectors

- Working knowledge of post market due diligence and vigilance

- International experience is a plus, but not required

- B.S. or B.A. in a health science, nursing or equivalent training

- RAC certification a plus

Candidates must be U.S. citizens or permanent residents. Relocation assistance is possible for an excellent candidate.

LOCATION:  Shelton, CT