Manager, Regulatory Compliance
|Job Id: 19945|
|Job Type: Permanent|
|Industry: MEDICAL DEVICES|
|Worksite Location: Headquarters office|
|Location: Sunnyvale, CA 94085|
(RELOCATION ASSISTANCE AVAILABLE)
Join a medical device that is considered a pioneer in the industry, offering one-of-a kind products and technologies. They owe their success to not only their products and science, but to the talent, passion, and commitment their employees display every single day… ARE YOU READY TO BECOME ONE?
They are seeking a talented Regulatory Compliance Manager to develop, define, educate, advocate, and manage a superior compliance culture throughout the company.
THE RIGHT CANDIDATE WILL HAVE:
- Bachelor’s degree in engineering field or equivalent
- 10+ years of experience in medical device industry, with 6 years related quality systems, quality auditing, and/or regulatory compliance experience
- Knowledge of domestic and international medical device quality system laws, regulations, and standards (such as 21CFR Part 820, ISO 13485:2016, ISO 14971, and ISO 11135)
- Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically.
- Project planning and management capability a must
- Computer knowledge: MS Word; MS Excel, MS Project, Visio, outlook, access, etc.
- Must be able to interpret device law into workable, efficient and effective practices and procedures.
- Lead auditor certification highly desired
WHAT THEY OFFER THEIR EMPLOYEES:
- Attractive salary + bonus
- Relocation benefits offered
- Comprehensive benefits package (Healthcare, Dental, Vision, Life Insurance, Long-term Disability, 401K)
- A culture of integrity, diversity, and the best technologies
WE’RE INTERVIEWING NOW!