JOB TITLE: Global Regulatory Specialist
Reports to: Director, Quality Assurance and Regulatory Affairs
Position Description: The Global Regulatory Specialist is responsible for leading regulatory activities pertaining to medical device and drug registrations in key markets around the world and supporting the QA/RA department with all other functions.
The Manager of Global Regulatory Affairs responsibilities include:
• Register medical device and drug registrations in key global markets, including the US, Europe, Canada, Australia, South America, and Asia, as well as support regulatory activities for smaller emerging international markets.
• Assist with registrations such as U.S. (FDA 510(k), PMN’s, PMA’s, and NDA’s), EU (CE Marking) and Canadian device / drug registrations
• Work with regulatory authorities and/or consultants as necessary to achieve company registration goals
• Communicate with Premier customers, suppliers, and internal staff to support the registration process for Premier products in various markets, including by submitting requests to the FDA for CFG’s, CPP’s and other Export Certificates
• Collaborate with the company’s QA/RA team to plan global registration strategies and to execute projects necessary to achieve departmental and company strategies
• Prepare, compile and review scientific / technical information prior to the submission to the regulatory authorities, maintain pertinent records and documents related to these submissions for the specified periods of time, and utilize document control procedures to effectively manage company records and documents where applicable (i.e. device master records, technical files, history files, and registration documents).
• Maintain the company’s database on international registration
• Collaborate with the company’s QA/RA team to maintain Premier’s Quality Management System and all related ISO Quality System registrations
• Assist in the updating or creation of SOPS, Work Instructions, and Forms
• Assist the QA/RA team during internal and external company audits.
• Lead adverse event / incident reporting, product withdraws and/or advisory notices or product recalls for all applicable global markets.
• Maintain a contemporary knowledge of current industry trends, standards and methodologies as they relate to regulatory and quality systems and management
• Train employees on regulatory and quality system matters.
• Apply a risk based approach to all applicable elements of the QMS
• Perform other duties as required
• 2+ years of global regulatory experience in a medical device company
• Bachelor’s degree in relevant field
• Proficiency in Microsoft Office programs such as Microsoft Word, Excel, Powerpoint
• Must possess excellent interpersonal, communication (written and verbal), problem solving and negotiating skills
• Excellent organizational, prioritization and time management skills
• Experience in training others in the quality management system
• Strong understanding of a medical company quality system
• Knowledge of and experience working with ISO 13485:2016
Contact Karen Giannone if interested, or if you need more information.