- CMJobPoster (Scarborough, ME)
- …is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and CMDR. This job description will be ... reviewed periodically and is subject to change by management. RESPONSIBILITIES: Perform testing of in-process components for Lateral Flow, ELISA and Molecular products Perform final release testing for Lateral Flow, ELISA and Molecular products Troubleshooting… more
- DivIHN Integration Inc (Woodland, CA)
- …Years and Area of Experience: Minimum 3 years' experience in Quality or Regulatory , preferably in a medical device , pharmaceutical or biotechnology ... of Position: Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality… more
- Arthrex (Goleta, CA)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... protected veteran status, or any other status protected by law.Arthrex, Inc. is a global medical device company and a leader in new product development and … more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...ISO 17665, etc. as well as domestic and foreign regulatory requirements; Coordinate all activities related to validations and/or… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... protected veteran status, or any other status protected by law.Arthrex, Inc. is a global medical device company leader in new product development and medical … more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...Regulatory and ISO guidelines for the development of medical devices required. Knowledgeable of medical … more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...Arthrex products will be printed. Support Packaging Engineering and Regulatory Affairs to develop labeling in compliance to company… more
- Arthrex (Pendleton, SC)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... protected veteran status, or any other status protected by law.Arthrex, Inc. is a global medical device company and a leader in new product development and … more
- Computer World Services (CWS)Corporation (Washington, DC)
- …making the results of the activities of the OFR available to financial regulatory agencies; and assisting such member agencies in determining the types of formats ... EDR, XDR, SIEM) and Trellix HX, handle firewall management and exceptions, device management, vulnerability management and mitigation. The ideal candidate will be a… more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... veteran status, or any other status protected by law.Arthrex, Inc, is a global medical device company and leader in orthopedics medical education. Arthrex… more
- Resolution Technologies, Inc. (Irvine, CA)
- …responsible for leading the design and implementation of security measures for medical device software, hardware, digital solutions and/or combinations products ... This role involves working closely with R&D, product management, regulatory , quality and compliance teams to ensure that all...Design: Develop and maintain a reference secure architecture for medical device products, ensuring that security is… more
- DivIHN Integration Inc (Atlanta, GA)
- …so 2-5 years of experience is acceptable. Industry experience, medical device Background in Electro-Mechanical devices are flexible Regulatory experience is ... inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic… more
- Software Galaxy Systems, LLC (Danbury, CT)
- …and implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device ... and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures… more
- DivIHN Integration Inc (Hayward, CA)
- …Bachelor's degree in relevant discipline or equivalent experience Experience with applicable medical device (21CFR820, ISO 13485, CMDR, MDD) and/or biologics ... of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirement. Write, revise and review SOPs. Perform QA on the floor… more
- ThermoFisher Scientific (Fremont, CA)
- …MINIMUM Experience Requirement: 5 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Affairs ... of study plus 8 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Affairs Specialist, or a related… more
- System One (Billerica, MA)
- …ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282) + Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, ... Device Regulation 2017/745 + Responsible as Management Representative, leading all regulatory inspections related to medical device and combination… more
- Bausch + Lomb (Bridgewater, NJ)
- …deadlines. + Other duties as assigned. **Requirements** **TECHNICAL COMPETENCIES:** Knowledge of medical device regulatory affairs discipline throughout the ... relating to submissions and regulatory approval of medical devices. Knowledge of medical device...without sacrificing attention to detail **Experience** 5+ years relevant medical device and regulatory experience.… more
- Kelly Services (Santa Rosa, CA)
- …and methods._ + **_Investigations, NCMR, CAPA and complaints._** + _Understanding of regulatory requirements for the medical device industry, specifically ... Device_** _experience for an exciting job opportunity with one of our Global Medical Device Manufacturing clients in_ **_Santa Rosa, CA_** _._ _Our client_ _is a… more
- Randstad US (Fort Worth, TX)
- …Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Medical Device Product Development Equal ... lead and oversee the strategic and operational aspects of regulatory labeling for medical devices. This role...and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA,… more
- Teleflex (Maple Grove, MN)
- …Summary** The Regulatory Affairs Specialist will develop strategies, submissions, and regulatory reviews of medical device marketing materials for ... Responsibilities** * Conduct regulatory review and approval of medical device marketing materials, including labeling, advertising, and promotional… more
