Senior Regulatory Affairs Specialist - boston - Arevna

Description

Job Summary:

The Senior Regulatory Specialist plays a pivotal role in ensuring global medical device registrations are compliant with regulatory policies. This individual will provide comprehensive regulatory expertise, collaborating with the Manager of Regulatory Affairs to manage daily departmental operations.

Key Responsibilities:

• Lead regulatory submissions, including CERs for EU MDR.
• Handle responses to regulatory authorities and work with cross-functional global teams to support regulatory affairs.
• Manage electronic and paper-based documentation to maintain compliance.

Requirements:

• Bachelor's or Master's degree with 5+ years in medical device regulatory submissions, preferably in fields like regulatory science, biology, chemistry, clinical research, or paralegal studies.
• Alternatively, 3+ years of experience with an advanced degree (PhD, PharmD, EdD, DBA, or D.Eng.).
• Regulatory Affairs Certification (RAC) is preferred.

Desirable Skills and Abilities:

• Strong technical and scientific writing skills as a primary author.
• Ability to interpret and apply country-specific regulatory requirements globally.
• Thorough knowledge of 510(k) and CE MDR processes and FDA/EU MDR standards for medical device submissions.

Working Environment:

• Remote work setup in the USA or Canada.
• CST or EST time zone only.
• U.S. Citizenship requirement.