Sr. Regulatory Affairs Specialist
Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?
It is an extraordinary time for Fluidigm. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.
At Fluidigm we are also building a positive culture where our people can do the best work of their careers, informed and influenced by our core values:
- Create what customers need next.
- Drive to make a difference.
- Collaborate and learn.
- Step up.
Fluidigm is looking for a Sr. Regulatory Affairs Specialist to join our team. Now is an exciting time for Fluidigm, and we want you to join us! We have placed our first In Vitro Diagnostic product on market and have pipeline of new products planned to make an impactful difference in clinical diagnostics. The quality and regulatory organization at Fluidigm is a cohesive group of professionals who enjoy what they do and have fun doing it! We invite all candidates who meet the qualifications below to apply for the opportunity to contribute to a dynamic and growing team.
- Conduct research on regulatory changes and developments and on application requirements and process.
- Assist in the development and review of procedures.
- Assist in the preparation of regulatory submissions to domestic and international Regulatory Agencies (e.g. FDA, Health Canada, etc.).
- Create Technical Files, Design Dossiers and Health Canada notifications of product changes for submission to the designated Regulatory Agency to obtain/maintain CE Marking.
- Review and Maintain Technical Files, Design Dossiers and Technical Documentation after receiving CE Marking.
- Advise responsible personnel on regulatory requirements and develop options with recommendations; develop product regulatory strategy; assess continuously project output and impact on regulatory strategy and launch date.
- Perform labeling reviews/approvals as required, including verification of printed product labels, instructions for use, advertising, and promotional materials.
- Compile and organize content of regulatory applications and files; assess acceptability and completeness of documents; identify unmet needs and provide feedback; ensure filing and timely retrieval.
- Support and assist with the external audit program and participate in inspections and audits by Regulatory Bodies.
- Complete Regulatory Corrective and Preventive Actions generated from audit findings.
- Develop and maintain policies and procedures regarding to regulatory submissions and processes.
- Interact with regulatory affairs staff to execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions.
- Additional duties and/or modifications to job description may occur at any time.
- Technical Degree (BS or higher) in a biological or chemical science.
- 5 - 8 years of experience working in IVD medical device quality assurance or regulatory affairs and with regulatory requirements such as ISO 13485, FDA (21 CFR 820, 803, 806, and 809) and European regulations/standards (IVDD/IVDR).
- Ability to work in a dynamic & fast paced environment.
- Must be a strong communicator with peers, team members, and management.
- Basic knowledge of QMS requirements (QSR and ISO 13485 and/or local GMP if appropriate) with developed knowledge of design and change controls.
- Familiar with IVD reagents, especially those used in molecular diagnostic tests (PCR).
- Prior experience interacting with regulatory agencies is a plus.
- RAC certification is a plus.
Ready to join an industry leader with a bold and ambitious mission that is enabling advancements in human health? Apply online with your resume!
Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.