THE COMPANY: Royal Biologics (www.royalbiologics.com) 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. (www.royalwx.com) 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.

Royal Biologics, Inc.

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