Regulatory Affairs Specialist

Main Responsibilities

• Define regulatory requirements necessary for regulatory approval of products in North America. Complete North American regulatory assessments as required to support projects and provide direction to project teams to support new product development and product modifications as required.
• Provide direction on application of external standards for all projects as required. Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for North America.
• Lead regulatory activities for product field corrective actions to maintain compliance and ensure that product approvals are properly maintained, and product re-submissions are properly managed.
• Assist in the development and implementation of required post-market surveillance.
• Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for international markets.
• Coordinates timely renewal of certificates, licenses, and registrations.
• Assist in creation of product labeling and instructions for use [package inserts] by collaborating with cross-functional business partners.
• Review and approve marketing literature and other items for compliance with relevant regulatory requirements.
• Assist in the development and implementation of the Physician Payments Sunshine Act.
• Author, review, and/or approve internal operating procedures related to regulatory affairs.
• Knowledge of Quality Systems Manual, Product Development, QSR & MDD, Complaint Handling.

Skills, Knowledge, Experience & Qualifications

• A bachelor's degree in a science or engineering concentration is required.
• Minimum of 5 years of experience in Regulatory Affairs
• Requires 5+ years' medical device industry experience including authoring PMA, IDE, and 510(k) submissions, preferably in the cardiovascular field.
• Experience with Class III devices required.
• Experience with Health Canada and international market submissions a plus
• Strong working knowledge and experience