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Company Contact Info
- San Diego, CA
- Dakota Lowe
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Senior Specialist/Senior Staff Specialist, Regulatory Affairs
EPM Scientific • San Diego, CA
Posted 1 month ago
Title: Senior Regulatory Affairs Associate/ Senior Staff Regulatory Affairs Specialist
One of the top 10 largest medical companies in the world is looking to grow out their Regulatory Affairs team at the San Diego facility. This specific medical device and consulting/analytics biotech has led the health care safety and technologies for more than a century. They consistently provide superior products and services. Their collaborations allow this biotech to lower costs of premier treatments and expand access to affordable health care.
We are looking for a seasoned Medical Device Regulatory Affairs Specialist to join the San Diego, CA facility at one of the largest biotech's in the world. The Regulatory Affairs Specialist role will develop Regulatory global strategy, domestic and international guidance, approval, and review. This role may include people and product management.
- Ensure regulatory compliance to FDA and international regulations
- Providing global regulatory strategy to contribute to labeling requirements, 510(k) submissions, and product marketing
- Work closely to provide knowledge of sterile disposable products, product biocompatibility, sterilization, and packaging requirements.
- May manage both people and products
- Amend current documentation and review product design
- Verify compliance to existing regulatory submissions
- Review content and format 510(k) and regulatory registration impact
- Provide knowledge of ISO/EU MDD/EU MDR/ and Canadian regulatory requirements
- Participate as a core member of the Regulatory Affairs team to develop projects and submissions
- Work hands-on in a dynamic fast-paced environment
Experience and Qualifications
- Minimum of 5+ years direct related professional experience in Regulatory Affairs/Quality required, preferably in the medical device/biomedical area
- Significant knowledge and experience working with software, instrument, and disposable design practices/products
- Ability to represent Regulatory Affairs in multiple environments (R&D, Marketing, Labeling)
- Interpret Regulatory Affairs documents, submissions, and reports
- Knowledge of current FDA regulatory requirements and trends for medical device premarket notifications
- Ability to present complex regulatory information to cross-functional teams
- Experience working and contributing to 510(k) and other regulatory submissions/documents
- Minimum of bachelor's degree or above in a life sciences field from an accredited college or university required
If you are interested in the Senior Specialist/Senior Staff Specialist of Regulatory Affairs role, do not hesitate to apply!