Regulatory Affairs Specialist

Regulatory Affairs Specialist

Requirements

• Bachelor’s degree in a technical discipline
• Minimum 2 years of experience in regulatory affairs or the medical device industry

Responsibilities

• Prepare US, EU, and international submissions for product changes as required to ensure timely approval for market release.
• Prepare regulatory strategies/plans and compliance requirements.
• Provide ongoing support to project teams for regulatory issues and questions.
• Provide business and product information to enable the development of strategies and requirements, as well as communicate that information to the project teams.
• Provide regulatory support for currently marketed products.
• Complete understanding and wide application of technical or regulatory principles, theories, and concepts.
• Participate in project team meetings to plan strategies.
• Provide regulatory product portfolio analysis and review with other functional resources.
• Maintain regulatory affairs product files to support compliance with regulatory requirements.
• Work under general supervision following established procedures.
• Keep current on global directives, harmonize standards and procedures, and communicate changes that may affect cross-functional areas.
• Provide training and support to other members of the department.

Preferred Qualifications

• Experience working in a regulated biotechnology environment, including regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and cross-functional project teams.
• 4+ years of medical device industry experience
• In-depth experience with FDA requirements, guidance documents, AIMDD/MDD/MDR requirements, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Experience with Class III medical devices (PMA)
• History of successful device submissions
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines