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:
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.
**Alternate Locations:** Work from Home**Work Arrangement:**Remote : Work at home employee**Relocation assistance:** is not available... ...financial security, with products including annuities, life insurance, group protection, and retirement plan services.With our 120...
...The Senior Director, Operations Excellence is a high-level leadership role responsible for driving and implementing strategic initiatives... ...Operations Excellence collaborates cross-functionally with key Restaurant Support Center (RSC) teamsincluding Marketing, Supply...
...Trust/Other Required: None Job Family: Cyber Security Job Qualifications: Skills: Cyber Defense, Cybersecurity, MITRE ATT&CK Framework, Threat Detection Certifications: Security+ - CompTIA Experience: 6 + years of related experience US...
...exclusive features.Role: Junior Node.js DeveloperJob Type: Contract - W2Location : New... ...Framework Utilization using HTML, CSS, JavaScript, TypeScript. Frameworks/Libraries:... ...resume to ****@*****.***Seniority level Entry levelEmployment type Full-timeJob function...
...animals) will be required. The Job - Thats what I do. Im a receptionist and I know things. We offer a full-time position of 34+... ...Sunday), with Sunday crew coming in for split shifts to care for hospitalized pets. Receptionists are also our after-hour operators and...