Medical Device, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
The Regulatory Affairs (RA) Specialist works with a cross functional project team to bring medical products to the market and to ensure ongoing compliance while continuing to develop their regulatory affairs skills. This position will facilitate product registrations globally as required by the business and facilitate product market withdrawals, product vigilance reports, liaise with competent authorities, facilitate product registration renewals and maintain EU technical files.
•Review of documentation generated during product development against current Design Control Process and regulatory requirements
•Create and maintain the Risk Management Documentation for new and existing products
•Support product and project managers as well as wider organization to meet product regulatory requirements for product registrations to support product launches.
•Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
•Write or update standard operating procedures to ensure that they reflect current regulatory requirements.
•Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
•Support creation of technical files for new products and implement updates for changes to existing products
•Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
•Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
•Conduct technical training sessions for colleagues.
•Bachelor's Degree in Engineering or Life Sciences
•3-5 years experience in RA within medical device or pharmaceutical industry
•Experience with ISO 13485:2016, IVD Regulations, FDA GMP and domestic/international Medical Device Regulations;
•Experience with support of cross functional new product development from RA perspective including risk management, review of technical files, new product approval and registration
•Ability to effectively communicate to all levels within the organization and influence change outside of the local span of control
•The ability to adapt in an environment of change, uncertainty, and ambiguity. Can pragmatically make decisions in a timely fashion, especially when there is not a clear path
•Excellent problem solving and presentation skills, learns a new environment quickly. Has the charisma and credibility to communicate and influence change at all levels within the organization;
•Identifies, communicates and implements the key priorities to the organization with little guidance or direction;
•A bias for taking action - spontaneous recognition of problems and opportunities. High sense of urgency; and,outstanding time and project management skills
Ability to Travel: 5-10%
Internal Number: COR001142
About Leica BioSystems
Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.
Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com for more information.
Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other cha