Regulatory Affairs Associate

Description

Ensures company and products are in compliance with applicable regulations and legislation. Assists in maintaining the appropriate establishment registrations as well as product registrations and/or licensing. Assist with the preparation, compilation, and review of regulatory submissions and related regulatory documents. Collaborate with manager, project teams, and functional area representatives to implement sound regulatory strategy.

• Assist in monitoring implementation of new regulatory / legal requirements (including environmental legislation) in the relevant countries.
• Maintain list of external standards.
• Assist Regulatory Affairs department in preparing and submitting regulatory submissions such as 510(k) notifications for the US market and other regulatory documents in support of specific country registration requirements.
• Work in partnership with other departments (i.e., engineering, quality, manufacturing, sales, marketing, etc.) as necessary to support regulatory submissions and regulatory compliance.
• Provide assistance with product vigilance/medical device adverse event reporting activities to include Medical Device Reporting (MDR) for the United States, and adverse reporting to Canadian authorities, etc.
• Assist in preparation and coordination of issuing Technical Bulletins or Advisories.
• Create and/or review product information in relation to Instructions for Use (IFUs), labeling, and sales and marketing literature.
• Create and/or revise Standard Operating Procedures, Work Instructions, etc. as directed.
• Assist with Regulatory Inquiries (internally and externally).
• Assist in preparation and maintenance of country specific technical documentation (US, EU, etc.).
• Assign and maintain Unique Device Identifiers (UDI) and database.
• Participate and assist in audits conducted by regulatory agencies, registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable.
• Verify product marketing authorization (by country) and support release of product in system for distribution/sale within the authorized country.
• Support with the creation and/or completion of Safety Data Sheets (SDSs), Toxic Substances Control Act (TSCA), etc., upon request.
• Support compliance with Environmental, Social and Governance (ESG) Requirements.
• Adhere to current Good Manufacturing Practices (cGMP).
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.

• High School Diploma or its equivalent.
• Legally authorized to work in the United States.
• Two (2) years proven quality and/or regulatory experience, within the medical device, In vitro diagnostics, biotechnology and/or pharmaceutical industries.
• Knowledge of ISO 9001, ISO 13485, and the Quality System Regulation (21 CFR Part 820).

• Bachelor's degree (B.A./B.S.) from an accredited college or university in a science related field.
• 4 years quality and/or regulatory experience in relation to medical device or In vitro diagnostics devices.
• Knowledgeable with ERP systems such as Pro Alpha, Oracle, SAP and AS400.
• Experience with regulatory submissions to FDA, EU Notified Bodies, etc.
• 1 year design and/or manufacturing experience.
• Qualified Auditor experience.

• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Good computer skills including Microsoft Word, Excel, Outlook.
• Excellent organizational skills to meet goals and set priorities.
• Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Initiative to offer new innovative ideas and improve processes.
• Ability to work independently and as a member of various teams and committees.
• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.