Sr Mgr, Regulatory Affairs NAM
Institut Straumann AG, Andover, MA, United States
Position Summary
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.
Job 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
Management Responsibilities
This position manages the following positions on a daily basis.
Direct: 1 to 3 Regulatory Affairs Specialists
Physical Attributes
General office environment. May sit for extended periods of time.
Physically able to bend, crouch and reach continuously while performing required job tasks.
Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence.
Physically able to spend significant time reading both on paper and on a computer.
Travel less than 5% both domestically and internationally.
Minimum Qualifications
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
Preferred Qualifications
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.)
Salary:
$128,00- $145,000/Annually.
The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type:
Full Time
Alternative Locations:
United States : Andover (MA)
TravelPercentage:
0 - 10%
Requisition ID:
20647
#J-18808-Ljbffr
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.
Job 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
Management Responsibilities
This position manages the following positions on a daily basis.
Direct: 1 to 3 Regulatory Affairs Specialists
Physical Attributes
General office environment. May sit for extended periods of time.
Physically able to bend, crouch and reach continuously while performing required job tasks.
Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence.
Physically able to spend significant time reading both on paper and on a computer.
Travel less than 5% both domestically and internationally.
Minimum Qualifications
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
Preferred Qualifications
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.)
Salary:
$128,00- $145,000/Annually.
The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type:
Full Time
Alternative Locations:
United States : Andover (MA)
TravelPercentage:
0 - 10%
Requisition ID:
20647
#J-18808-Ljbffr