Regulatory Affairs Manager

CHE - Kloten - Nobel Biocare

R5027682

Switzerland

Quality and Regulatory Affairs

Job description

The Regulatory Affairs Manager is responsible for regulatory affairs deliverables related to the EU, US and Canada for product development, compliance projects, lifecycle management, and regulatory processes, for prosthetic and digital devices. The role also contributes to the responsible use of AI and automation to improve regulatory processes and operational efficiency.

Main responsibilities:

• Manage the regulatory aspects of developing new prosthetic and digital devices. Develop and execute regulatory strategies and assemble high-quality deliverables for CE/UKCA marking, 510(k) and Health Canada submissions.
• Manage the regulatory compliance of prosthetic and digital devices throughout their lifecycle, including supporting change requests and sustaining projects; revising and updating technical files (STEDs and GSPRCs); handling claims; supporting post-market surveillance (PMS); and assessing risks for devices affected by HHEs, deviations, CAPAs or recalls.
• Support internal and external quality management system audits and technical file reviews, including audit preparation and front- and back-office support.
• Execute and maintain product and economic operator registrations with authorities. Ensure accurate, timely and compliant UDI submissions and data integrity across relevant regulatory systems and jurisdictions.
• Support the creation and maintenance of regulatory procedures and processes; conduct country risk assessments; and gather regulatory intelligence to keep processes current and compliant with local regulations.
• Provide regulatory guidance on global labeling and instructions for use (IFU), including eIFU, and support the maintenance of compliant content throughout the product lifecycle.
• Provide regulatory guidance for software and connected digital solutions, including regulatory applicability, security risk management, post-market considerations and lifecycle changes.
• Identify practical AI and automation opportunities within Regulatory Affairs by analysing end-to-end processes and identifying steps suited to automation or AI while preserving human judgment. Assess feasibility, risks, controls and expected benefits; define appropriate governance and validation requirements.

Job requirements

• A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused on technology or science is preferred.
• Minimum 5 years’ experience in regulatory affairs within medical device industry.
• Minimum 3 years' experience in working directly with authorities
• In depth knowledge of core aspects of EU, US and CA medical device regulations.
• Knowledge of medical device quality management system requirements (ISO 13485).
• Knowledge of core aspects of the design control process and the requirements for technical documentation for medical devices.
• Experience of devising regulatory strategies and conducting impact assessments.
• Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
• Working knowledge of software, cybersecurity risk management and post-market surveillance is an advantage.
• Foundational knowledge of AI and automation concepts and the ability to support their responsible use in optimising Regulatory Affairs and Quality Assurance processes, with appropriate consideration of data quality, validation, human oversight and traceability.
• Fluency in English is a must. Further languages are an advantage.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan.

• Operating Company:

Nobel Biocare

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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Nobel Biocare

Operating Company:

Nobel Biocare

Location:

CHE - Kloten - Nobel Biocare

Date Posted:

October 22 , 2026

Req Number:

R5027682

Benefits

Caring for our employees and their families

Health & Wellbeing

We offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally.

Retirement & Financial Benefits

We are committed to supporting our employees’ financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers.

Life & Disability Insurance

We provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events.

Paid Time Off

We know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most.

Learning & Career Development

We believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us.

Our hiring process

At Envista, we’re committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives.

1. Application Review

After you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps.

2. Interviews

You’ll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact.

3. Offer Decision

If selected, you’ll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision.

4. Onboarding

Once you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.