BD (Becton, Dickinson and Company) Senior Regulatory Affairs Specialist (m/w/d) - Medical Devices in Karlsruhe, Germany
Job Description Summary
About the Role
In this role, the Senior Regulatory Affairs Specialist (m/w/d) - Medical Devices will be working with BD’s latest technologies across a broad portfolio of products which includes arterial and venous stents and stent grafts. This is a highly visible role within the organisation, and you will participate in cross-functional teams as the regulatory medical device expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc.).
Inputs to development of regulatory strategies and provides guidance and expertise.
Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
Prepares and presents gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner.
Reviews and approves the project documentation (design reports, labeling, etc.).
Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.
For this role you will hold a relevant degree and have 3+ years’ experience in a similar position in the medical device industry. You would have worked with regulatory submissions with exposure to implantable devices. Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971) is a must, knowledge of FDA and international regulatory requirements is a plus.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
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