- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This S enior Regulatory Affairs Manager - APAC position will work on-site ... glucose levels with our new sensing technology. This Senior Regulatory Affairs Manager - APAC...region for Diabetes care's projects. Work closely with in-country regulatory representatives, compile, prepare, and review medical device… more
- Foresight Diagnostics (Boulder, CO)
- …diverse schedules, including evenings, weekends, and holidays. This position reports to the Senior Manager of Regulatory Affairs . What You Will Do *Support ... Foresight Diagnostics is headquartered in Boulder, Colorado. About The Role The Regulatory Affairs Specialist supports our product teams supporting new product… more
- Intuitive (Sunnyvale, CA)
- …Engineering (PLE), and other cross-functional supporting teams to ensure the company's regulatory affairs activities are conducted in accordance with company ... regulatory changes to support strategic decision-making. Maintain a knowledge base of regulatory affairs guidelines in China and Hong Kong, providing input on… more
- Cepheid (Miami, FL)
- …Market Quality, and other Quality related functions.This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is part of ... This includes assessing complaints cross functionally for reportability decisions to regulatory authorities, ie, submitting Vigilance and Medical Device … more
- Capstan (Santa Cruz, CA)
- …minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a ... valve treatment! Description We are seeking a Clinical Trial Manager to lead premarket clinical studies for Capstan Medical...relevant regulations. As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to… more
- Hologic (San Diego, CA)
- …of clinical program strategy together with key stakeholder departments (eg R&D, Regulatory Affairs , Marketing, Scientific Affairs ). Leads and manages ... Clinical Affair group is hiring for a Clinical Program Manager (CPM) here in San Diego! As a CPM,...goals and objectives Excellent working knowledge of GCP, clinical affairs , and regulatory affairs The… more
- Vertex Pharmaceuticals (Boston, MA)
- …internal cross-functional teams, including Analytical Development, AS&T, CMC, Supply Management, Regulatory Affairs , Program Management and Quality Assurance, as ... Job Description General Summary: The Manager of Quality Control will be responsible for...and internal procedures. Work with CMC technical SMEs and Regulatory to prepare and review QC related sections of… more
- Veterans Health Administration (Memphis, TN)
- …and systems; technology implementation including site preparation, incoming inspections, device /system integration, network device security implementation and ... multimeters. Maintains functional knowledge of relevant safety codes and standards of regulatory bodies including, but not limited to, The Joint Commission (TJC),… more
- CorDx (Atlanta, GA)
- …820, ISO 13485, and other relevant standards. Collaborate with R&D, Manufacturing, Regulatory Affairs , and Operations teams to integrate quality requirements ... users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …EMA). Strong attention to detail and organizational skills. Licenses: RAC ( Regulatory Affairs Certification)Preferred Certified Quality Auditor (CQA) or ... identification, quality plan for new requirements, site inspection readiness, and regulatory authority (FDA, ) inspection support. Essential Functions: Lead network… more
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible for ... and product marketing strategy for product portfolio which been assigned. + Regulatory affairs professionals actively participate on NPI (new product… more
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations ... + Act as the key liaison between the global regulatory affairs team and other departments, such...solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on… more
- Abbott (Sylmar, CA)
- …fingersticks. Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management ... The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to ... and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory. Minimum… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Regulatory Affairs Manager for a direct-hire position at a cutting-edge client in South San Francisco, CA . If ... if candidate is located in the West Coast.** The Regulatory Affairs Manager or Sr...global RA department. + Seeks expert advice and develops device regulatory product strategies and identifies data… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical device… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …United States of America **Job Description:** We are searching for the best talent for ** Manager , Regulatory Affairs ** to support the Power Tools team within ... be considered as a single submission. **Purpose** : The Manager , Regulatory Affairs will lead,...(6+ years with Master's, 5+ years with PhD); Medical Device regulatory experience _strongly preferred_ . +… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work ... glucose levels with our new sensing technology. This **Senior Regulatory Affairs Manager - APAC**...for Diabetes care's projects. + Work closely with in-country regulatory representatives, compile, prepare, and review medical device… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... team in Sylmar CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory … more
