Develop and implement medical device regulatory strategies for administration and safety systems
Author and review complex product submissions guidance and negotiate submission issues with Agency personnel
Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams
Prepare US, EU, and other international submissions for new products and product changes
Work with RA team to build Regulatory strategies for medical device development platform
Provide leadership to product development teams for regulatory issues and questions
Provide support to market-released products as necessary

Bachelor's Degree science, math, engineering, life sciences or related discipline required
Minimum 8 years related work experience required
Medical device or Combination Product regulatory experience preferred
Excellent oral communication and technical writing skills
Advanced knowledge of product life cycle, product development, design control and change control
International regulatory competency
Experience with administration and safety systems preferred
Minimum US Class I and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745)
History of successful US 510(k) device and EU technical documentation submissions
Experience directly interacting with government agencies
Strong negotiation and decision-making skills

Principal Specialist, Regulatory Affairs

Key skills