Senior Regulatory Specialist

The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. The role will also involve authoring 510k submissions, creating EU MDR Technical Documentation, and leading interactions with regulators/competent authorities throughout the review and approval process.

Requirements

• Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience 510(k) experience is preferred.
• Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.
• Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision.

Benefits

• Opportunity for mentoring and coaching other regulatory team members
• Participation in process improvement teams to affect changes at a local or cross business unit level