Manager, Regulatory Affairs (Medical Devices)
|Job Id: 20190|
|Job Type: Permanent|
|Industry: MEDICAL DEVICES|
|Worksite Location: Headquarters|
|Location: Fremont, CA 94539|
Join a leader that is renowned throughout the medical device industry as well as the tech world! They are super passionate about creating innovative products that are life-transforming.
They’re also passionate about hiring the best: They’re looking to hire a “go-getting” and “out-of-the-box” thinking Manager, Regulatory Affairs.
ABOUT THE POSITION…
In the role of Manager, Regulatory Affairs, you will develop strategies to ensure regulation compliance. The Manager, Regulatory Affairs, will also provide regulatory guidance to departments and/or development project teams in regards to the design, development, evaluation, or marketing of products.
THE RIGHT CANDIDATE HAS…
- BS degree in a related field of study; and a minimum of 10 years of related experience and/or training; or equivalent combination of education and experience
- Hands-on and knowledge of PMS/ UDI/ MDD / MDR and ISO 13485
- Strong knowledge and understanding of UDI and FDA portal
- Knowledge and ability to advise others on legal or regulatory compliance matters
- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submissions, and maintenance
- Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
- Regulatory Affairs Certification is preferred
WHAT YOU’LL RECEIVE…
- Attractive salary + bonus
- Rich comprehensive benefits package
- Relocation benefits
- A culture of integrity, latest technologies, and top talent
We’re Interviewing NOW!