- Medtronic (Irvine, CA)
- …for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. ... with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... License Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical… more
- Leica Biosystems (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global ... Medical Affairs /MSL training and continued education plans related to Eisai's...credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/ international regulations as they ... an effective Industrial QMS that provides compliance to relevant international standards, customer requirements and regulatory requirements.Maintains oversight… more
- Cleerly (Denver, CO)
- …be listed as requirements in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide regulatory support and ... or higher degree in a Life Science, Engineering or related discipline. Regulatory Affairs Certification (RAC) preferred. Demonstrated knowledge and experience in… more
- Betco Corporation, LTD (Bowling Green, OH)
- Develop, implement and coordinate compliance with federal, state, local and international regulatory requirements applicable to Institution cleaning chemicals, ... stewardship. Able to provide technical advice with respect to regulatory affairs to internal team members and...Compliance on labels and (M)SDS's according to US and International requirements. Monitor activities at the federal, state and… more
- Lexington Medical (Bedford, MA)
- …of patients worldwide and thrive in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and execute a regulatory ... product approvals and clearances. Qualifications: Bachelor's degree in Science, Engineering, Regulatory Affairs , or other technically related field. 5-8+ years… more
- Abbott (Minneapolis, MN)
- …get on with their lives. The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. ... including those set by the FDA or other worldwide regulatory agencies to various international affiliates. Maintains...etc.), math, engineering, or medical fields. Master's degree in Regulatory Affairs . Regulatory experience with… more
- Capstan (Santa Cruz, CA)
- Reports to: Head of Regulatory Affairs (SVP, RA) Workplace type: Hybrid Description: This is a unique opportunity for an experienced Regulatory Affairs ... positioned to revolutionize structural heart care. The Manager of Regulatory Affairs will help build and execute...PMAs, etc.) in collaboration with the team. Work with international affiliates to compile and submit international … more
- Intuitive (Sunnyvale, CA)
- … regulatory agencies on regulatory issues and submissions. *Support international regulatory efforts as needed. *Perform other duties as required. ... Company Description Job Description New Product/Indication Submissions Provide regulatory insight to development, new product introduction, and manufacturing teams… more
- Prismatik (Irvine, CA)
- …field preferred Minimum five (5) years of experience in Regulatory Affairs . Experience in preparing (writing) domestic and international product submissions, ... submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in the US, Canada,… more
- BioSpace (Indianapolis, IN)
- …living with cancer and those who care for them. Our oncology global medical affairs team seeks to understand, generate, and share key data, science, and insights in ... cancer patients. The clinical research physician (CRP) in Lilly Oncology's Global Medical Affairs organization will help accelerate the impact we can have on patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… more
- International SOS Government Medical Services (Denver, CO)
- Company Description International SOS Government Medical Services, Inc. delivers customized medical and security risk management and wellbeing solutions to enable ... in 92 countries providing integrated medical solutions to organizations with international operations. Our innovative technology and medical and security expertise… more
- Omnicom Health (New York, NY)
- …a unique model of four powerhouses- Commercial & Marketing, Medical Affairs , Publications, Regulatory - that enables hyperconnected, audience-centric engagement ... patients. Together, we accelerate the impact of science. Associate Scientific Director ( Regulatory ) We are seeking a seasoned Associate Scientific Director with a… more
- VB Spine LLC (Allendale, NJ)
- …discipline Minimum 1 year of experience in medical device labeling and/or regulatory affairs Understanding of medical device regulations and standards (eg, ... Regulatory Labeling Specialist Location : Leesburg, VA or...and standardize content Coordinate translation of labeling and support international label strategies Review and approve supplier-generated labels and… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Tata Consultancy Service Limited (Irvine, CA)
- …& ISO ( International Organization for Standardization) 13485 and regulatory affairs *Strong creative, analytical and problem-solving skills. *Proficient ... reports, and procedures, is accurate, up-to-date, and compliant with regulatory requirements. *Experience with statistical techniques like Design of Experiments… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
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