Straumann Group
Position Title: Director, Regulatory Affairs NAM
Location/s: Andover (MA), United States
Job Category: Quality Assurance
Company: STUS - Straumann US
Description:
#ChangeMakers
Ready to make an impact?
We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others
We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.
#WeChangeDentistry every day. Be part of it.
Position Summary:
The Director, Regulatory Affairs is responsible for administering Straumann North America’s regulatory function in accordance with company, FDA, and Health Canada requirements. Formulates and establishes associated regulatory procedures for company in close collaboration with the Sr. Director, Regulatory Affairs and Quality, as well as with Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) regulatory teams. Develops, coordinates, and manages regulatory pathways for FDA and Health Canada submissions, including but not limited to Pre-Submissions, 510(k)s, PMAs, IDEs, and License Applications in close collaboration with the corresponding Straumann Group company regulatory teams.
Job Responsibilities:
This position is responsible for, but not limited to, the following:
- Develop, analyze, implement, and provide feedback on regulatory strategies for products planned for NAM in consultation with Straumann Group company regulatory affairs.
- Responsible for establishing working relationships and leading Straumann Group interaction with the FDA and Health Canada regarding pre-submissions, product clearance, approval, or licensing and establishment registrations and device listings.
- Lead negotiations with FDA and Health Canada on complex issues.
- Prepare, review, and/or direct the development of documentation for various regulatory submissions (Pre-Submissions, 510(k)s, PMAs, IDEs, Annual Reports, and License Applications) and Memos-to-File.
- Provide strategic input and technical guidance to product development teams regarding NAM regulatory requirements.
- Act as the US agent for Straumann Group companies as needed.
- Evaluate the impact of proposed product changes and assess prepared documentation for regulatory filing strategy.
- Manage the regulatory release of new products and address any regulatory import/export issues.
- Responsible for regulatory compliance review of product labeling, advertising, and promotional materials for NAM.
- Maintain knowledge of the standards that apply to assigned products and/or projects and monitors any relevant development of new standards or regulations.
- Monitor FDA and Health Canada guidance and rulemaking and Congressional activity to maintain awareness of the current FDA and Health Canada thinking and to anticipate the future regulatory landscape.
- Conduct on-going surveillance regarding competitive regulatory activities as part of the Regulatory Intelligence function.
- Monitor for and lead opportunities with FDA and Health Canada to participate in relevant pilot programs and Experiential Learning Programs.
- Recruit, manage, and mentor junior RA staff members to form a high-performance RA team that can efficiently manage and complete regulatory projects for NAM and globally.
- Establish effective communication with executives and managers to ensure that company objectives and regulatory requirements are met.
- Review and interpret regulatory rules as they relate to clinical studies, engineering testing, and product documentation and ensure that they are communicated appropriately and where applicable in alignment with regulatory authority expectations for NAM.
- Prepare and control budgets for NAM regulatory affairs.
- Communicate regulatory timelines and activities to NAM lead team.
- 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 in cross country projects as needed.
- Other duties as assigned.
Management Responsibilities:
This position manages the following positions on a daily basis.
- Direct: 1 to 5 Regulatory Affairs Specialists
Physical Attributes:
- General office environment. May sit for extended periods of time.
- Hybrid Model: Enjoy a balanced work-life with 3 days in the office and 2 days remote.
- 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 science or engineering field.
- 10+ years of experience in a medical technology company with regulatory, quality, or clinical experience.
- 5+ years of management of a regulatory group within a medical technology company or 5+ years of experience operating within a global, matrix-management environment.
Preferred Qualifications:
- Experience negotiating and interfacing with FDA and Health Canada.
- Experience with FDA and Health Canada inspections.
- Experience with FDA and Health Canada submissions for all Classes of products.
- Excellent written and oral presentation skills.
- Excellent organizational skills with strong attention to detail and the ability to multi-task effectively
- Strong analytical skills combined with a solutions-oriented mentality.
- Strong leadership skills, demonstrating a track-record of success in a high-growth environment.
- Experience with both consumable and durable medical technologies preferred.
Additional Information:
Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.
- 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!
Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.
Videos To Watch:
https://youtu.be/3lq5BLAvIdQ
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)
Travel Percentage: 0 - 10%
Requisition ID: 18463
Equal Opportunity and Affirmative Action Employer (US applicants only)
Straumann Group is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national origin, age, veteran status, or disability unrelated to job requirements. Straumann Group will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, Straumann Group has developed and maintains an affirmative action program and plan.
We comply with the Employee Polygraph Protection Act (EPPA), and Massachusetts law. It is unlawful for private employers to use lie detector tests for pre-employment screening or during employment, except in limited circumstances. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Equal employment opportunity, including veterans and individuals with disabilities.
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