Regulatory​/Quality Assurance Supervisor or Manager

Job Description

Company Overview: Our client is a leader in the manufacturing industry, dedicated to delivering high-quality products that meet rigorous regulatory and safety standards. Our commitment to innovation and excellence drives us to continually improve our processes and ensure compliance with global regulations. We are seeking a dedicated Regulatory/Quality Assurance Supervisor or Manager to join our team and uphold our standards of quality and regulatory conformance.

Job Description: The Regulatory/Quality Assurance Supervisor or Manager will ensure that our products meet the requirements of the FDA, ISO 13485, European MDR 2017/745 (CE), Japanese Ordinance 169, and other relevant regulatory agencies. This role involves managing the company's regulatory and quality programs, maintaining certifications, and implementing regulation-driven changes to our quality management system. The ideal candidate will possess a deep understanding of regulatory requirements and will work closely with the Management team to support our business and manufacturing practices.

• Ensure compliance with FDA, ISO 13485, European MDR 2017/745, Japanese Ordinance 169, and other regulatory agencies.
• Manage the company's regulatory and quality programs under the supervision of the Director of Regulatory and Purchasing.
• Maintain and develop product technical documentation, quality manuals, and risk management files.
• Report on the effectiveness of the QMS and recommend improvements.
• Promote awareness of regulatory and QMS requirements throughout the organization.
• Act as the back-up Person Responsible for Regulatory Compliance (PRRC) and Management Representative during QMS audits.
• Serve as the back-up Local Actor Administrator (LAA) for the Economic Operator regarding the EUDAMED database.
• Develop and maintain up-to-date Declaration of Conformities and product technical documentation.
• Conduct supplier audits and participate as an active member of the UWI Validation Team.
• Perform process re-validations as necessary and ensure product incident reports meet regulatory requirements.
• Maintain regulatory records, including PMS, PMCF, and PSUR documentation.
• Provide customers with quality agreements, contracts, and technical documentation as needed.

• Bachelor's degree in a related field.
• Minimum of 5 years of job‑related experience with specific related training.
• Strong communication and interpersonal skills for effective interaction at all organizational levels.
• Ability to manage multiple priorities and multitask efficiently.
• Proficiency in Microsoft Applications:
  Word, Excel, Outlook, and other relevant software systems.
• Proven leadership abilities and a track record of achieving results through others.
• In‑depth knowledge of current regulations and the ability to anticipate and prepare for future requirements.

• Experience in maintaining compliance with international regulations and standards.
• Familiarity with product classifications, CE labeling, and validation requirements.
• Experience in developing and maintaining quality systems and regulatory documentation.

• Competitive salary and performance‑based bonuses.
• Health, dental, and vision insurance.
• Professional development opportunities and ongoing training.
• Collaborative and supportive company culture.
• Generous paid time off and holiday schedule.
• 401(k) and 401(k) matching.
• Life insurance.

Job Type: Full‑time

Schedule:

8 hour shift

Ability to Relocate:
Bristol, CT 06010 – Relocate before starting work (Required)

Work Location:

In person