Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
San Jose, CA 94088
About the Job
Responsibilities :
- Work with cross-functional teams to provide regulatory guidance during the development of Class III Medical Devices
- Establish the regulatory strategy and global registration plan for products, meeting internal quality system requirements and product development process expectations.
- Prepare regulatory submissions, including applications for Investigational Device Exemption and Premarket Approval, and submit them to FDA.
- Communicate directly with FDA reviewers and work with internal cross-functional teams to address FDA feedback.
- Support regulatory intelligence efforts by monitoring for new or changed FDA regulations and guidance documents and new or revised industry standards, assessing for impact, and communicating among the organization.
- Provide regulatory support for clinical and post-market activities including adverse event reporting, labeling updates, and regulatory inquiries.
- Bachelor's degree required, science or technical are preferred.
- Minimum of 3 years regulatory affairs experience required with Bachelor's degree.
- Minimum of 2 years regulatory affairs experience with Advanced degree.
- US Class III Medical Device experience preferred (e.g. IDE, PMA).
- EU MDR experience preferred.
- Ability to effectively manage multiple projects and priorities.
- Experience working with cross-functional teams.
- Excellent written and verbal communication skills
- Strong Organizational skills and attention to detail.
- Self-motivated and able to work independently.
Source : Katalyst Healthcares & Life Sciences
