REGULATORY AFFAIRS ASSOCIATE

TRUMBULL, CT

The Regulatory Affairs Associate will provide the internal regulatory affairs support for development and post-marketing of Class II and III medical devices. The incumbent will develop, implement and maintain regulatory affairs strategies. At the direction of the Director of Regulatory Affairs & Compliance, the Regulatory Affairs Associate monitors the regulatory environment and provides assessments of the impact of new and changing regulations.

Key Functions

1. Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international.

2. Supports International Standards Organization implementation and maintenance.3. Reviews Medical Device Regulatory standards and updates to ensure compliance.4. Notifies Supervision and Management of Product safety issues.5. Assists with maintaining and updating Order Entry Restrictions database.6. Assembles, Reviews and updates “Technical Files”, prepares “Declarations of

Conformity” (MDD).7. Provides liaison with FDA, Notified Body, and Authorized European Reps.8. Processes and updates CFGs.9. Assists in the development of Part 806 documents for recalls, field actions and advisory

notifications, including effectiveness checks.10. Assists in UDI process development and EU Rep conversion.11. Assist with support for CAPA & IQA program as required.12. At the Direction of the Director, provides tactical and strategic support of the Cooper

Product Development and Product Acquisition efforts, including:

Establishing regulatory strategy, and overseeing the submission/approval process with domestic and international regulatory bodies.

Establishing and implementing global regulatory strategies with cross-functional teams to assure compliance and approval.

Ensuring compliance with regulatory standards worldwide.

1. Maintains collaborative relationship with R & D, Marketing and Operations is required.2. Maintains collaborative relationships with external partners including regulators and

external companies with established supply/distribution agreements (as applicable) is required.

3. Performs additional duties as required by management.

 

Qualifications:

 

1. Bachelor’s Degree in Sciences, Engineering, Technical or equivalent. Master’s Degree a plus.

2. Minimum 10 years quality, regulatory, compliance manufacturing, operations and/or engineering is required

3. Command of Medical Device QSRs, ISO 13485, MDD 93/42/EEC, Canadian Regulations.

4. Three - Five years QA/RA experience in the medical device or related industry.5. Strong communication and problem solving skills.6. Advanced computer skills.7. Project organizational skills.8. Passing of background check, which may include verification of prior employment,

criminal conviction history, educational and driving records.