Regulatory Affairs Specialist
1 week ago
- Provides administrative support for regulatory affairs manager
- Provides RA support for change control projects and sustaining activities
- Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)
- Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product team
- Responds to requests for product information by customers or other businesses
- bility to carry out the above tasks with minimal supervision
- Experience with disposable medical devices
- Experience with International registrations and renewal.
- Minimum Bachelor's degree; strongly preferred in science or engineering
- Minimum 1-3 years' experience in Regulatory Affairs in the medical device industry
- Demonstrated customer service, cross-functional collaboration, and teamwork skills
- Proven ability to manage multiple project deliverables and meet project timelines
- Effective written and verbal communication skills
- Scientific and analytical evaluation skills US FDA medical device regulations, standards, and guidance
- 21 CFR 820 - Quality System Regulation.
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Regulatory Affairs Specialist
4 weeks ago
South Plainfield, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Oversee the day-to-day functions of the regulatory initiatives for Hassen Implants, Digital, and Biomaterial Solutions. Develop regulatory strategies for new, existing, and modified medical devices and other regulated products. Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions....
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Regulatory Affairs Specialist
3 weeks ago
South Plainfield, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Oversee the day-to-day functions of the regulatory initiatives for Hassen Implants, Digital, and Biomaterial Solutions. Develop regulatory strategies for new, existing, and modified medical devices and other regulated products. Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions....
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Regulatory Affairs Associate
4 weeks ago
South San Francisco, United States Cytokinetics Full timeReporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. **Responsibilities** - Prepare and/or coordinate and comply routine regulatory submissions and other...
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Regulatory Affairs Associate
5 days ago
South San Francisco, California, United States Cytokinetics Full timePrepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines Review regulatory documents to ensure that all submissions are complete, accurate and meet re Regulatory Affairs, Regulatory, Associate, Business Services
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Director, Regulatory Affairs
3 weeks ago
South San Francisco, United States Maze Therapeutics Full timeThe Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...
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Director, Regulatory Affairs
1 month ago
South San Francisco, United States Maze Therapeutics Full timeThe Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...
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Director, Regulatory Affairs
2 months ago
South San Francisco, United States Maze Therapeutics Full timeJob DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...
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Director, Regulatory Affairs
1 month ago
South San Francisco, United States Maze Therapeutics Full timeJob DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...
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Director, Regulatory Affairs
3 weeks ago
South San Francisco, United States Maze Therapeutics Full timeJob DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...
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South Plainfield, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages, and distributes vaccines for animals. Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA...
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Associate Director, Regulatory Affairs
2 weeks ago
South San Francisco, United States Cytokinetics Full timeReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. **Responsibilities** - Formulate regulatory strategies, with supervisor oversight, based on current...
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Regulatory Affairs Consultant
4 weeks ago
South San Francisco, United States People With Chemistry Full timeOur client is seeking a high level Regulatory consultant specializing in Immunology. In this role, you will lead strategic regulatory efforts. In addition, act as Global Regulatory Lead, shape global expansion and clinical registration strategies. Responsibilities: •Devise global regulatory strategies, serve as an expert leader. •Craft & review accurate...
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Regulatory Affairs Consultant
3 weeks ago
South San Francisco, United States People With Chemistry Full timeOur client is seeking a high level Regulatory consultant specializing in Immunology. In this role, you will lead strategic regulatory efforts. In addition, act as Global Regulatory Lead, shape global expansion and clinical registration strategies. Responsibilities: •Devise global regulatory strategies, serve as an expert leader. •Craft & review accurate...
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Senior Manager, Regulatory Affairs
5 days ago
South San Francisco, California, United States Cytokinetics Full timeFormulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provid Regulatory Affairs, Manager, Regulatory, Senior, Business Partner, Business Services
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Regulatory Affairs Manager
2 months ago
South San Francisco, United States AbbVie Full time**Company Description** **Job Description** Key Responsibilities** - Responsible for providing regulatory strategy & support for global development. - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project...
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Regulatory Affairs Manager
1 day ago
South San Francisco, United States AbbVie Full time**Company Description** **Job Description** Key Responsibilities** - Responsible for providing regulatory strategy & support for global development. - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project...
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Global Director of Regulatory Affairs
4 weeks ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...
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Global Director of Regulatory Affairs
3 weeks ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...
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Global Director of Regulatory Affairs
3 weeks ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...
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Senior Associate, Regulatory Affairs
4 weeks ago
South San Francisco, United States Allogene Full timeAbout Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...