Manager - Quality & Regulatory Affairs

United States of America, New Jersey, Mahwah | United States of America, Michigan | USA
- Lubbock
- Osteogenics Biomedical, Inc.

- OB1 R5027371

United States of America Quality and Regulatory Affairs 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 discipline5+ 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.#LI-MM1

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