Director Regulatory and Quality Systems

Position Summary
The Director of Regulatory & Quality Systems is responsible for leading the company's regulatory strategy and ensuring the effectiveness of the Quality Management System (QMS) in alignment with FDA, ISO, and other applicable regulatory requirements. This role oversees regulatory submissions, compliance activities, internal and external audits, and quality system performance for a portfolio of Class II medical devices. As a key leader in a public company, this individual ensures regulatory readiness, drives continuous improvement, and partners cross functionally to support product development, commercialization, and ongoing lifecycle management.

Accountabilities & Responsibilities
Regulatory Affairs Leadership
* Develop and execute regulatory strategies to support new product introductions, modifications, and ongoing compliance for Class II medical devices.
* Lead preparation, submission, and maintenance of regulatory filings including 510(k)s, technical files, annual reports, and global registrations.
* Serve as primary liaison with FDA and other regulatory authorities; manage communications, inspections, and responses.
* Monitor evolving regulatory requirements and proactively assess impact on the business.
* Provide regulatory guidance to R&D, Clinical, Marketing, and Operations teams throughout the product lifecycle.
Quality Systems Management
* Oversee the company's Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards.
* Lead internal and external audits, including FDA inspections and notified body audits; ensure timely and effective CAPA management.
* Drive continuous improvement initiatives across quality processes, documentation, and system performance.
* Oversee Post Market Surveillance to ensure robust processes for complaint handling, nonconformance management, supplier quality, and risk management.
* Partner with Operations and Engineering to ensure quality is embedded throughout manufacturing and product development.
Leadership & Cross Functional Collaboration
* Lead and develop a high performing Regulatory & Quality team, fostering accountability, technical expertise, and professional growth.
* Collaborate with executive leadership to align regulatory and quality strategies with business objectives.
* Provide regular updates to senior leadership on compliance status, regulatory risks, and quality metrics.
* Represent the company in regulatory and quality matters with external partners, auditors, and stakeholders.
* Other duties as assigned.

Education & Experience
Required:
* Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field.
* 10+ years of experience in Regulatory Affairs and/or Quality within the medical device industry.
* Proven leadership experience managing regulatory and quality functions for Class II medical devices.
* Strong working knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and related standards.
* Demonstrated success preparing and submitting 510(k)s and interacting with FDA.
* Experience leading audits, inspections, and crossfunctional compliance initiatives.
Preferred:
* Advanced degree (MS, MBA, RAC, or equivalent).
* Experience in a publicly traded company, including familiarity with SOX and corporate governance expectations.
* Background supporting global regulatory submissions (EU, Canada, APAC).
* Experience with combination products or digital health components (if applicable).

Knowledge & Skills
* Strong expertise in FDA regulations (21 CFR Part 820, Part 11) and ISO standards (ISO 13485, ISO 14971).
* Proven experience with Class II medical devices, including 510(k) submissions and design controls.
* Deep understanding of Quality Management Systems and continuous improvement practices.
* Ability to lead regulatory strategy and interpret requirements for crossfunctional teams.
* Skilled in managing FDA inspections, notified body audits, and regulatory communications.
* Strong analytical skills with the ability to assess data, identify trends, and drive CAPA actions.
* Proficient in risk management tools such as hazard analysis and FMEA.
* Solid understanding of product development from concept through commercialization.
* Excellent communication and executivelevel presentation skills.
* Demonstrated leadership ability to build and develop highperforming teams.
* Strong judgment, integrity, and decisionmaking in regulated environments.
* Effective project management skills with the ability to prioritize and deliver in fastpaced settings.