Sarnova is the leading national specialty distributor of health care products in the emergency medical services (EMS) and respiratory markets. The company operates through several market-leading distributors including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, EMP and Cardio Partners, a full Sudden Cardiac Arrest Solution provider that specializes in CPR Training, Program Management, AEDs, Defibrillators, Accessories and Service.
We offer more than 100,000 health care products to 20,000 hospitals and emergency care providers across the country. Sarnova is the only national distributor that can offer expertise and support across multiple specialty health care markets.
The Regulatory Specialist will be responsible for assisting with the Company’s compliance with all laws and regulation and managing risk relating to its private label products and kitting business.
Essential Duties and Responsibilities:
· Assist with the due diligence and/or audit of new and existing private label product manufacturers.
· Review labels for Company’s private label products and kits to ensure labels contain the appropriate UDI, instructions for use, contraindication and other required information.
· Support the implementation of corporate quality goals and action plans for the Company’s private label products and kitting business.
· Draft and revise standard operating procedures, policies and records, including those relating to the Company’s ISO certification.
· Assist in conducting root cause and potential preventative/corrective actions.
· Ensure timely closure of product investigations.
· Manage customer complaints and relevant trends.
· Work closely with the production and supply chain departments to ensure compliance with cGMP
· Manage compliance with federal importation laws.
· Assist in company audits and collaborate with operations to develop and implement processes to fill gaps identified in audit findings and law changes.
· Bachelor’s degree.
· 3 to 5 years of quality or regulatory experience
· Direct experience in the medical device or pharmaceutical industry desired.
· Demonstrated familiarity with FDA, DEA and state regulations and the application of sound Quality Systems to ensure compliance.
· Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomes.
· Ability to interact and communicate professionally and effectively with internal and external customers including regulatory agencies.
· Strong written and verbal communication skills.
· Well-developed organizational and cross functional skills.
· Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software.
· General Counsel
Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled