Sr. Quality & Regulatory Associate – Long Island, NY area

Top Medical Device company, leading the industry in service, quality products and strategic partnerships is seeking a QA/RA hybrid professional. This company has been in business for over 20 years and has consistently sustained double-digit growth annually. Employees stay for the positive, collaborative work environment and great team members.

The ideal candidate will have a collaborative disposition and the following qualifications:

• Bachelor’s degree with 5 to 7 years of Quality Assurance & Regulatory Affairs experience
• Experience working with medical device products, to include preparation and compliance of labels and packaging for local and international regulatory entities
• Familiarity with manufacturing processes including importing and sterilization processes
• Expert knowledge in Domestic and International registrations and filings (ISO, CAPA, 510K, FDA, UDI, NCR, CMDR & EU MDR)

You will be responsible for the regulatory process throughout the product development life cycle, to include, but not limited to:

• Aiding in the development of regulatory strategies to support product development
• Providing guidance and regulatory feedback throughout the product development life cycle
• Creation of regulatory documents for product submissions or compliance actions
• Work with appropriate departments to ensure applicable materials are developed for new product submissions
• Submittal of all FDA documentation and registrations, ensuring products meet regulatory requirements
• Ensuring all reporting requirements are met under European MDD/MDR, CE and Canadian MDSAP
• Management of vendor Certificates of Compliance system and maintaining the Regulatory Master files in conjunction with the international office
• Ensuring full compliance with FDA and Health Canada, MDR, and EU MDR regulations and ISO requirements
• Staying current with all compliance procedures and regulatory enforcement actions
• Maintaining the highest levels of product quality by managing the coordination of activities between quality assurance and other departments

** Occasional international travel to the corporate location is required

If qualified, let’s connect to discuss the details. It’s a terrific opportunity for a someone looking to progress to a manager level at a great company and grow their career.

Keywords: ISO, CAPA, 510K, FDA, UDI, NCR, CMDR, product listing, product registration, medical device, disposable. ETO, gamma, sterilization, EU MDR, MD SAP