Manager - Quality & Regulatory Affairs

Envista; Mahwah (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health & Wellbeing

Retirement & Financial Benefits

Life & Disability Insurance

Paid Time Off

Job summary

Versah, LLC, now part of the Envista family, seeks a Regulatory Affairs leader to develop global strategies and maintain regulatory approvals for its medical device portfolio. You will collaborate with R&D, Engineering, Quality, Operations, Marketing, and Sales to support product lifecycle activities.

The role emphasizes compliance with 21 CFR 820, ISO 13485, and EU MDR, while guiding audits and regulatory interactions across markets.

Qualifications

• Bachelor’s degree in scientific or technical discipline.
• 5+ years in medical device regulatory affairs with quality systems exposure.
• Strong knowledge of medical device regs and quality systems (e.g., 21 CFR 820, ISO 13485, EU MDR).
• Experience leading regulatory strategies and engaging with global authorities.
• RAPS certification or formal regulatory training preferred.
• Excellent written and verbal communication; able to influence at multiple levels.

Responsibilities

• Develop and lead global regulatory strategies for Versah’s medical device portfolio.
• Interpret regulations and translate into product/project requirements.
• Prepare, submit, and maintain international regulatory filings; liaise with health authorities.
• Provide regulatory guidance to cross-functional partners for new product development and sustaining activities.
• Ensure alignment with Envista/Nobel Biocare frameworks and maintain QMS.
• Support audits, supplier qualification, CAPA, and document control.
• Oversee import/export regulatory compliance and global UDI compliance.
• Monitor changes in global regulations and communicate impact.

Skills

Regulatory strategy

Quality systems

Global communication

Independent work

Cross-functional collaboration

Education

Bachelor's degree in scientific/technical field

Tools

eCTD submissions

Regulatory databases

Job description

United States of America, New Jersey, Mahwah | United States of America, Michigan | USA - Lubbock - Osteogenics Biomedical, Inc. - OB1R5027371United States of AmericaQuality and Regulatory AffairsJob descriptionVersah, LLC is a pioneer in dental osteotomy and bone densification technologies and is now part of Nobel Biocare, a global implant and regenerative solutions leader within the Envista family of brands. Powered by its patented Densah Bur technology and Osseodensification approach, Versah helps clinicians worldwide enhance implant site preparation and regenerative procedures.This role supports global regulatory compliance while contributing to the maintenance and continuous improvement of the Quality Management System. It is well suited for a highly coachable regulatory professional with a solid RA foundation and working knowledge of quality systems who is eager to expand into broader quality system ownership over time.Success in this role means enabling global market access while maintaining audit-ready compliance, and it offers a strong opportunity to join a collaborative team and grow into increased ownership and leadership over time.Duties and responsibilities:Develop and lead global regulatory strategies to secure and maintain approvals for Versah’s medical device portfolio, with primary ownership of emerging markets.Interpret global and regional regulations and translate them into clear product, project, and business requirements across the full product lifecycle.Prepare, submit, and maintain international regulatory filings; serve as the primary contact for health authorities, including negotiation and timely resolution of regulatory questions.Provide regulatory guidance to cross-functional partners (R&D, Engineering, Quality, Operations, Marketing, and Sales) to support both new product development and sustaining activities.Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks, and drive maintenance and continuous improvement of the Versah Quality Management System in accordance with applicable regulations and standards.Support and participate in external, third-party, and regulatory audits/inspections in collaboration with Regulatory and Quality leadership.Support supplier qualification, incoming inspection/material review, and nonconformance management; support complaint investigations and CAPA; and maintain product traceability, quality records, and document control.Oversee import/export regulatory compliance and ensure adherence to country-specific requirements for product distribution.Manage and maintain global UDI compliance across all applicable markets.Conduct regulatory assessments to inform business planning, market expansion, and product lifecycle decisions.Monitor, interpret, and communicate changes in global medical device regulations to drive ongoing compliance and organizational awareness.Job requirementsQualifications/skills:Bachelor’s degree in scientific or technical discipline5+ years of experience in medical device regulatory affairs, with exposure to quality systemsStrong working knowledge of medical device regulations and quality systems (e.g., 21 CFR 820, QMSR, ISO 13485, MDD & EU MDR).Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities.RAPS certification or formal regulatory training are preferred.Excellent critical thinking, problem‑solving, and decision‑making skills.Strong written and verbal communication skills with the ability to influence at multiple organizational levels.Proven ability to work independently, manage multiple priorities, and lead cross‑functional collaboration.#LI-MM1IND123Target 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.-Operating Company:Nobel BiocareEnvista 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.pdfRead moreNobel BiocareOperating Company:Nobel BiocareLocation:United States of America, New Jersey, Mahwah | United States of America, Michigan | USA - Lubbock - Osteogenics Biomedical, Inc. - OB1Date Posted:September 16 , 2026Req Number:R5027371BenefitsCaring for our employees and their familiesHealth & WellbeingWe 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 BenefitsWe 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 InsuranceWe 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 OffWe 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 DevelopmentWe 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 processAt 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 ReviewAfter 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. InterviewsYou’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 DecisionIf 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. OnboardingOnce you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.