Staff Specialist, Regulatory Affairs

BD

83d

About The Position

This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, leads interactions with regulatory agencies/notified bodies, reviews design control documents and product labeling, and evaluates proposed device changes. This position interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.

Requirements

• Bachelor's degree or higher
• 6-8 years' Regulatory Affairs experience in the medical device industry
• Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
• Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
• Proven experience owning and managing the end-to-end process of regulatory approvals/clearances
• Experience with product development processes and design controls
• Excellent written and verbal communication skills
• Strong negotiation skills
• Problem-solving and analytical skills
• Detail-oriented with organizational skills to manage multiple tasks
• Ability to work in a team-oriented, fast-paced environment
• Proficiency in Microsoft Office tools

Nice To Haves

• Master's degree in Regulatory Affairs
• Regulatory Affairs Professional Society (RAPS) certification
• Bachelor's degree specifically in a scientific discipline
• Experience mentoring other regulatory colleagues
• Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
• Subject matter expertise in regulatory affairs
• Ability to be effective in complex projects with ambiguity and rapid change

Responsibilities

• Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met
• Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market
• Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements
• Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval
• Leads interactions with FDA, EU notified bodies, and other regulatory agencies on submissions and other issues
• Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications
• Communicates changes to global regions and supports preparation of global notifications as needed
• Understands fundamental global regulatory requirements and different regulatory pathways
• Stays informed of new regulations and changes to existing regulations and communicates to project teams
• Identifies and communicates appropriately quantified risks and mitigation strategies associated with regulatory changes to partners
• Maintains regulatory databases and systems
• Supports regulatory body audits, CAPAs, and other compliance activities
• Reviews advertising and promotional material
• Participates in claims development strategy
• Leads training related to areas of expertise
• Mentors other regulatory colleagues

What This Job Offers

• Education Level: Bachelor's degree