Regulatory Affairs Specialist

Pay rate: $38.46/hr

Hours: Core hours 10-3, flexible start/finish. 40 hours per week total

Location: Andover, MA. Hybrid- Work location address for onsite and hybrid: Mansfield or Andover

Duration: 1 year

Role Overview :

Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval.

Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body.

Maintains databases asrequired.

Supports regulatory compliance projects as assigned.

Responsibilities:

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.

Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations.

Trains to and executes document management within local Product

Lifecycle Management system and other electronic documentation systems as applicable.

Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.

Other activities as assigned.

Benefits (employee contribution):

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.