Manager - Quality & Regulatory Affairs

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

Job summary

Versah, LLC, now part of Nobel Biocare Envista, seeks a regulatory affairs professional to lead global regulatory strategies for its medical device portfolio. You will interpret regulations, prepare filings, and serve as contact with health authorities across emerging markets.

You are a coachable RA professional with QA experience, aiming to grow into broader quality ownership while ensuring audit-ready compliance and alignment with Envista and Nobel Biocare frameworks.

Qualifications

• Bachelor’s degree in scientific or technical discipline.
• 5+ years in medical device regulatory affairs.
• Experience leading regulatory strategies and interacting with global authorities.

Responsibilities

• Develop and lead global regulatory strategies for medical device portfolio.
• Interpret global/regional regulations and translate into product requirements.
• Prepare and maintain international regulatory filings; liaise with health authorities.

Skills

Regulatory strategy

Global regulatory affairs

Cross-functional collaboration

Communications

Problem solving

Regulatory leadership

Education

Bachelor’s degree in scientific/technical discipline

Tools

21 CFR 820

QMSR

ISO 13485

MDD & EU MDR

Job description

Job Description

Versah, 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 Requirements

Qualifications/skills: Bachelor’s degree in scientific or technical discipline 5+ years of experience in medical device regulatory affairs, with exposure to quality systems Strong 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.

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.

Operating Company

- Operating Company: Nobel Biocare 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: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. 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 is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry‑leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.