Sr. Regulatory Affairs Specialist

Location: North Haven, Connecticut

**About the Role**

We are seeking a seasoned Regulatory Specialist with a focus on medical device regulatory compliance. This role involves coordinating and preparing document packages for regulatory submissions, leading the compilation of materials required for submissions, and recommending changes for regulatory compliance. The position requires a deep understanding of US FDA and EU MDR regulations, as well as experience with medical device manufacturing and design changes.

**Responsibilities**

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
• Lead the compilation of materials required for submissions, license renewals, and annual registrations.
• Recommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
• Monitor and improve tracking and control systems.
• Stay updated on regulatory procedures and changes.
• Direct interaction with regulatory agencies on defined matters.
• Recommend strategies for the earliest possible approvals of clinical trial applications.
• Deliver and manage projects from design to implementation, adhering to policies and using specialized knowledge.
• Provide guidance, coaching, and training to other employees within the job area.

**Education Qualification**

• Bachelor's degree required.

**Required Skills**

• 3-5 years of experience in medical device regulatory compliance, specifically in change assessment with a focus on US FDA and EU MDR.
• Experience with medical device manufacturing process changes and design changes.
• Familiarity with US (510k, LTF, deciding when to submit) and EU (change notifications with Notified Bodies) regulatory processes.
• Advanced knowledge of regulatory compliance and project management.
• Strong communication skills for interacting with senior internal and external customers and vendors.
• Ability to work independently under limited supervision and manage projects/processes.
• Experience in providing recommendations on process improvements and influencing decision-making.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.