Senior Manager, Regulatory Affairs NAM

Straumann • Andover, MA

1d

About The Position

The Senior manager, Regulatory Affairs is responsible for developing and executing regulatory strategies for assigned product portfolios and projects across North America (US and Canada). This role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams.
The Senior Manager provides strategic regulatory guidance to support product development, commercialization, and lifecycle management while ensuring compliance with FDA and Health Canada requirements. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.

Requirements

• Bachelor’s Degree in a scientific, engineering, or related discipline.
• 7-10 years of experience in a medical technology company with regulatory, quality, or clinical experience.
• 5+ years of people management or demonstrated team leadership experience

Nice To Haves

• Experience developing regulatory strategies and leading FDA and Health Canada submissions for all device classes
• Strong working knowledge of FDA and Health Canada regulation and guidance
• Experience negotiating and interfacing with FDA and Health Canada
• Strong project management and organizational skills with the ability to manage multiple priorities
• Excellent written and verbal presentation skills.
• Strong analytical and problem solving skills with a solutions-oriented mindset.
• Experience across multiple device types (e.g., capital equipment, consumables, implants, software as a medical device, etc.)

Responsibilities

• Develop and execute regulatory strategies for assigned products and projects in alignment with North America and global regulatory objectives
• Lead the planning, preparation, and submission of regulatory submissions (e.g., Pre-Submissions, 510(k)s, PMAs, IDEs, and Health Canada License Applications) to support product approvals and lifecycle management
• Serve as the NAM regulatory representative on cross-functional project teams, providing guidance on regulatory requirements, risks, and timelines
• Lead interactions with FDA and Health Canada reviewers for assigned submissions, including responding to questions and managing communications in alignment with leadership
• Assess the regulatory impact of product changes and define appropriate regulatory pathways and documentation strategies
• Review and approve regulatory documentation, including submissions, Memos-to-File, labeling, and promotional materials to ensure compliance with applicable regulations
• Partner with global regulatory teams to ensure alignment on regulatory strategies, submissions, and change management activities
• Monitor evolving regulatory requirements, guidance documents, and industry trends to inform regulatory strategy and maintain compliance
• Contribute to regulatory intelligence activities, including competitive landscape assessments and interpretation of new regulations and standards
• Support regulatory operations activities as needed, including establishment registrations, device listings, and import/export compliance
• Manage the regulatory release of new products and address any regulatory import/export issues.
• Ensure regulatory deliverables are completed in accordance with project timelines and quality expectations
• Identify risks and proactively propose mitigation strategies to support successful regulatory outcomes
• Monitor for and lead opportunities with FDA and Health Canada to participate in relevant pilot programs and Experiential Learning Programs.
• May represent Regulatory Affairs in internal audits and support external inspections as needed
• Directly manage, coach, and develop regulatory affairs staff, with full accountability for performance management, development planning, and team effectiveness
• Develop and monitor appropriate metrics to track regulatory and process improvement.
• Develop and deliver training regarding NAM Regulatory Affairs activities for Straumann Group globally and support cross-country projects as needed.
• Other duties as assigned.

Benefits

• Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level