- Actalent (San Clemente, CA)
- …degree (Master's or Ph.D.) preferred. + 5+ years in the medical device industry focusing on biocompatibility, regulatory compliance , or quality assurance. + ... Description The Quality Assurance Specialist will lead the evaluation of medical devices against biological evaluation standards. This role involves reviewing… more
- Actalent (Lake Forest, CA)
- …FDA, regulatory submission, Regulatory reporting, Test plan, Regulatory compliance , Compliance , Quality engineering, Medical device , Regulatory affairs, ... both new product development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory, new… more
- Quality Consulting Group (Juncos, PR)
- …Bachelor's degree in Science or Engineering + 8+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, ... FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. + Proven experience leading FCA and CAPA processes, ideally… more
- ConvaTec (NJ)
- …as needed. **Skills & Experience:** + Demonstrated knowledge of HTS classification of medical device products. + Knowledge and experience working in customs ... License + Food and Drug Administration agency experience in health care ( medical device ) **Dimensions:** **Team** **_No direct reports._** **Principal Contacts &… more
- Lundbeck (Deerfield, IL)
- …of Compliance -related experience in the healthcare industry (ie. pharmaceutical, medical device , biologics, healthcare or consulting company that supports ... Compliance -related experience in in the life sciences, pharmaceutical, biotech or medical device industry. This may include consulting experience or in-house… more
- Advanced Energy (Wilmington, MA)
- …+ Ability to work well in a team environment + Experience in medical device firmware and/or designing in compliance with IEC 62304 an advantage + Experience ... data acquisition systems. + Implement advanced software development techniques in compliance with technical reference architecture + Participate in on-going code… more
- Actalent (Irvine, CA)
- …Services LLC, you will play a pivotal role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. ... plans and conducting reviews. What We're Looking For + Experience with medical device product development lifecycle, including risk management and design/process… more
- CalSTRS (Sacramento, CA)
- Job Posting: Investment Officer III, Investment Compliance State Teachers' Retirement System JC-501517 - Investment Officer III, Investment Compliance INVESTMENT ... an Investment Officer III (IO III) on the Investment Compliance team. CalSTRS Investment Performance & Compliance ...+ Flexible work hours + Remote work options + Medical benefits, including health, dental and vision insurance +… more
- Danaher Corporation (Marlborough, MA)
- …implement any required remedial actions. + Review of promotional content, including medical device promotional materials. The essential requirements of the job ... program experience is preferred, but not required + Experience with FDA medical device promotional regulations. SCIEX, a Danaher operating company, offers a… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders ... premier WCD on the market. ESSENTIAL DUTIES + Manage the development, delivery and compliance requirements of a robust medical education program, inclusive of a… more