New · posted Oct 15
Envista · Medical Devices
Manager - Quality & Regulatory Affairs
- Lubbock, TX +2 more
- On-site
- Full-time
- Manager
Open until filled
The role
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.
What you need
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.
IND123
What you'll do
- 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.
Pay and benefits
Envista didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
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.
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Annual performance bonus
Medical/dental/vision benefits
401K match
Where you'll work
Lubbock, TX +2 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Michigan · Mahwah, NJ
More jobs in Lubbock, TX +2 moreEqual opportunity, accessibility and legal noticesEnvista's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $146,750 | $162,500 | $177,750 |
Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Envista's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Collaboration and leadership10
- Quality systems and risk5
- Documentation and SOPs2
- Regulatory submissions2
- Investigations and CAPA1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
Envista on Regulatory Jobs
- 7
- Open roles
- 6
- Distinct roles
- 6
- Locations
By discipline
- Regulatory4 57%
- Quality3 43%
By level
- Manager3 43%
- Associate & Specialist3 43%
- Senior & Principal1 14%
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Manager - Quality & Regulatory Affairs at Envista
Open until filled.