A direct-hire/permanent Principal Regulatory Affairs Specialist job is available in San Diego, CA via Real Staffing. This position is with a leading diagnostic company focused on creating best in class products that provide more timely, precise information, leading to improved treatment outcomes.
We are seeking an experienced individual contributor to be responsible for the coordination, leadership and execution of pre and/or post market Regulatory Affairs departmental functions as assigned by management. This role acts as a subject matter expert that helps to ensure compliance with applicable US and international regulations in which the company does business; preparing product submission documentation for US and international markets, and evaluating product changes for effects on regulatory license registrations.
- Lead in the preparation and submittal of regulatory data required for market clearance, licensing, registration and legalization in both the US and various international markets.
- Participate in New Product Development cross-functional teams as the RA core team member
- Review product change requests and notifications for assessment to regulatory impact to licenses.
- Draft Product Change Notifications for dissemination to international businesses for local regulatory impact
- Review promotional labeling material for compliance to approved indications and supported claims
- Work with Clinical core-team members on clinical submissions and maintaining Clinical Evaluation Reports
- Develop global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information on FDA clearances/approvals of competitors, and proactively shares this information with regulatory team.
- Maintains the company's FDA regulatory files, including regulatory submissions, FDA deficiency letters, company responses, clearances/approvals, labeling, and all associated correspondence.
- Leads efforts to respond to regulatory questions from regulatory agencies and/or customers.
- Participate in meetings with regulatory agencies (e.g., pre-sub meetings)
- Supports product complaints as required with regulatory and product expertise
- Serve as Regulatory team representative on various cross functional teams
- Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements so as to keep ahead of changes in the regulatory climate. Integrate these changes in work plans.
- Bachelor's degree required (Life Science preferred)
- 6-8+ years of applicable regulatory affairs (RA) experience, preferably within an in-vitro diagnostics environment
- Industry recognized certification (e.g. RAC) preferred.
- Must possess demonstrated advanced knowledge of FDA regulations, EU Directives, and various international medical device and IVD regulations gained from in-depth work experience
- Must possess a demonstrated history of compliance with regulations and procedures and provide transparency to management regarding all work related issues
- Must possess extensive knowledge of Regulatory Affairs as it applies to the product life cycle as well as other related processes gained from work experience
If you are interested in this position please apply directly with your current resume.
Sthree US is acting as an Employment Agency in relation to this vacancy.