Job Description

POSITION : Quality and Regulatory Manager

LOCATION : Hybrid (2 days/week in Hackensack, NJ)

THE COMPANY: Royal Biologics ( is a developer and distributor of consumable orthobiologics and orthopedic devices, providing a broad suite of differentiated products to hospitals and surgery centers nationwide. The Company’s products leverage autologous and live cellular therapies to treat a broad range of musculoskeletal and regenerative medicine needs, primarily related to orthopedic surgeries. Royal has a blue-chip customer base across 20+ states, selling through an in-house salesforce and a robust network of third-party distributors. Royal is headquartered in Hackensack, NJ. This position will work with Quality and Regulatory systems of Royal Biologics and its sister company, Royal Wound-X. () Royal Wound-X distributes similar devices and biologics, but for use in the treatment of advanced wounds.

POSITION SUMMARY:

Royal Biologics is in search of a Quality and Regulatory Manager to join our growing team, responsible for the management and execution of day to day Quality and Regulatory systems. This position is a critical team member and will work collaboratively to ensure patient safety, product effectiveness, and quality/regulatory compliance.

IDEAL CANDIDATE :

The ideal candidate can work independently, has strong cognitive abilities, and 5+ years experience in Quality Assurance and/or Regulatory Affairs in a Medical Device or Human Tissue company. They must be able to own, develop, and manage Quality/Regulatory systems with minimal oversight and must have working knowledge of 21CFR820 and ISO13485:2016, Working knowledge of 21CFR1271 and the AATB Standards of Tissue Banking is a plus.

KEY RESPONSIBILITIES:

· Manage and execute daily QA and Regulatory activities including Change Control, Document Control, Deviations/Non-Conformances, CAPAs, Supplier Management

· Ensure the timely documentation, execution, and completion of quality records

· Support regulatory (FDA, ISO) and customer audits

· Support ongoing and new projects from a Quality/Regulatory perspective

· Provide record review and Quality release of Sterilization and Finished Goods

· Manage renewal of Regulatory registrations and licensing

REQUIREMENTS:

• 3+ years of relevant work experience
• Experience within Quality and Regulatory in a regulated life sciences company (Medical Device, Biologics, Pharmaceutical, or Human Tissue)
• Ability to work independently
• Effective time and project management skills
• Technically proficient
• Experience working in electronic Quality Management Systems
• Ability to support supplier audits a plus

BENEFITS : Medical, optional dental, vision, 401(k), disability insurance, life insurance, HSA and FSA options

This job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change.

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