Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

The Regulatory Affairs Specialist II supports regulatory submissions and regulatory authority interactions related to product submissions and approvals. In this role, you will prepare and submit regulatory documentation, support product market approval and post-approval activities, and provide regulatory guidance to cross-functional teams to ensure compliance with applicable requirements.

• Prepares regulatory documentation packages for review and submission to regulatory agencies and commercial partners to achieve departmental and organizational objectives.

• Prepares, submits, and archives 510(k)s, Letters to File, EU MDR technical documentation, and Change Notifications.

• Responds to FDA and Notified Body (NB) submission queries and supports regulatory authority interactions.

• Provides regulatory support for post-launch business maintenance activities under the guidance of Senior Regulatory Affairs personnel.

• Reviews labeling and engineering changes for compliance with regulatory filings.

• Maintains current knowledge of FDA, ICH, and international regulatory guidelines and requirements.

• Collaborates with cross-functional teams and commercial partners to support regulatory submissions, product changes, and post-approval activities.

• Performs other duties and projects as assigned.

This role is responsible for supporting regulatory submissions and product lifecycle activities that are essential to maintaining regulatory compliance and supporting product market approval. The position requires strong attention to detail, organizational skills, and the ability to manage multiple priorities in a fast-paced, changing environment. Success in this role requires sound regulatory judgment, effective communication, strong follow-through, and the ability to work independently while collaborating effectively with cross-functional teams and commercial partners.

• Bachelor's degree, preferably in Life Sciences or a related field, or equivalent experience.

• 2+ years of regulatory affairs experience.

• Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.

• General understanding of global and U.S. regulatory processes.

• Strong organizational and follow-up skills, with excellent attention to detail.

• Excellent project management skills with the ability to manage multiple priorities and meet deadlines.

• Ability to work effectively within a team and independently as an individual contributor in a fast-paced, changing environment.

• Excellent written and verbal communication skills, including presentation skills and the ability to effectively present information using presentation platforms.

Hybrid position based in Bedford, MA