Regulatory Affairs Manager – Cancer/ In Vitro Diagnostics
August 30, 2018
Full Time - Experienced
Clinical Trials, Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
This is a management position providing expertise and management of the Regulatory Affairs (RA) function for our cancer in vitro diagnostics business. Responsible for a broad spectrum of global regulatory needs, including premarket and post-market regulatory affairs to support Leica’s growing business. The Manager will ensure RA deliverables are coordinated across multiple LBS global regulatory experts working in a highly matrixed environment.
Will serve as the site RA representative to regulators and Notified Bodies for routine matters
May include specialized responsibilities in adverse event reporting (MDR, Vigilance, HHE), registrations/submissions, regulatory intelligence, compliance, device listing, communications with regulatory bodies, recalls and field actions, advertising & promotion, regulatory support of new product development and device change processes
Experienced in multiple areas of medical device regulatory affairs and is capable of applying that experience and in-depth knowledge to work independently with minimal guidance from management
May lead small projects with manageable risks and resource requirements
Responsible for planning, organizing and conducting duties related to assigned areas of the site’s regulatory obligations. May include one or more of the following areas:
Review and approve labeling, advertising and promotion for compliance to applicable regulations
Track the progress of new and updated regulations that impact the business (regulatory intelligence)
Implementation of new regulations
Identify and implement new or updated regulations that are routine or do not have a major impact on the business
In conjunction with management, develop plans to implement regulations that have a significant impact on the business (e.g. IVDR, UDI, Companion and Complementary Diagnostics)
Participate and contribute to LBS or Danaher councils for regulatory intelligence and compliance
Submissions, registrations, device listings, site licensesServe as site RA representative on new product development teams and change management initiatives
Establish and maintain device listings and licenses according to government requirements
Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function
Bachelor’s degree in science, medical or technical field and 5+ years’ experience with increasing responsibility in IVD/Medical Device Regulatory Affairs; graduate or advanced degree preferred
Direct Supervisory/Management experience of RA professionals
Experience in the IVD field preferred experience very beneficial
Requisite training or certification in medical device Regulatory Affairs through on-the-job training, seminars, training; relevant certifications preferred
Travel expectations are approximately 10-15%
Telecommuting is allowed.
Internal Number: 0001053
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