Regulatory Affairs Manager (6 month contract)

This is a 6 month fully remote contract opportunity, however incumbent needs to be based in the US.

Job Summary: The Regulatory Affairs Contractor will be responsible for managing and executing regulatory submissions to ensure compliance with global medical device regulations. This role involves preparing and submitting regulatory documents, maintaining regulatory files, and providing guidance on regulatory matters to cross-functional teams and to external regulatory agents.

Key Responsibilities:

• Prepares (i.e. plans, writes and reviews) the sections of the marketing application for international submissions.
• Works with cross function teams and external regulatory agents to coordinate requirements for regulatory submissions.
• Maintains regulatory files or records, including archive of submissions and correspondence files.

Qualifications:

• Bachelor's degree in Life Sciences, or a related field.
• Minimum of 3 years of experience in regulatory affairs within the medical device industry.

• Must work independently. The candidate should have experience preparing, writing, and submitting regulatory submissions.
• International regulatory submission experience that can assess and judge the required content to include in the submission.

• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.

• Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.

• Detail-oriented with a high level of accuracy.
• Strong organizational skills and ability to drive projects to completion within deadlines.

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