Do you possess an exceptional attention to detail and the ability to communicate technical information in a clear and concise manner? If so, come join us as a…
Regulatory Affairs Associate - Cambridge, MA
As a member of the Miltenyi Biotec Regulatory Affairs Team, you will be responsible to support all company regulatory objectives to ensure that products meet worldwide regulatory requirements on all aspects of product approval and post-marketing compliance. In addition, you will act as a regulatory liaison for medical and clinical research groups to keep the regulatory affairs department apprised of research progress. Overall, you will be a key contributor to the continued success of all submissions to North American regulatory agencies.
- You have a B.S. degree in life sciences or chemistry and 1-3 years’ experience with regulatory filings
- You have a strong background supporting regulated clinical trials and experience with investigator initiated clinical trials, with a working knowledge of FDA guidelines and submissions.
- You have excellent written and verbal communication skills
- You are highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint & Outlook)
Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.
We empower great science. For more than 25 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 1,800 scientists, engineers, physicians, support specialists, marketers, and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.
Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability