Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

Role and Responsibilities

• Define the regulatory strategy for product maintenance for existing approved products.
• Team with other operating unit regulatory personnel and international regulatory staff to provide support for new products/therapies and changes to existing products.
• Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies, including reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
• Prepare regulatory (e.g., FDA/Notified Body) submissions for product changes to ensure timely approvals for clinical studies and market release.
• Review significant product submissions with manager.
• Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level.
• Support regulatory compliance activities, including manufacturing site registration and audits, as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
• Provide feedback and on-going support to product development teams for regulatory issues and questions.
• Develop proficiency in domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
• Ensure personal understanding of all quality policy/system items that are personally applicable.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.

Must Have: Minimum Requirements

• Bachelor's degree required
• Minimum of 2 years of experience in regulatory affairs in the medical device industry, or advanced degree with a minimum of 0 years of experience in regulatory affairs in the medical device industry

Nice to Have (Preferred Qualifications)

• Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences)
• Experience with 510(k)/IDE/PMA device product submissions, EU regulations (MDR) and other worldwide submissions and clearances
• Experience performing advertising and promotion reviews for medical devices
• Experience with FDA and international regulatory agency requirements
• Effective interpersonal skills
• Effective team member
• Ability to comprehend principles of engineering, physiology and medical device use
• Ability to effectively manage multiple projects and priorities
• Proficient computer skills
• Project management skills
• Excellent oral and written skills
• Excellent analytical thinking skills