What are the responsibilities and job description for the Regulatory Affairs Specialist position at Predicine, Inc?
Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development.
Predicine has developed an international business utilizing its innovative liquid biopsy technology and molecular insights to empower biopharma partners in clinical drug development and expand opportunities around new oncology medicines. Fully recognized by global industry leaders, we are partnering with a slate of top 10 MNC BioPharmas to support biomarker-driven clinical trials in US, EU, APAC including China.
At Predicine, we believe people are our most important asset and we are dedicated to creating a great place to work. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.
We invite people who share the same values to join us!
The Regulatory Affairs Specialist will support submission activities for Predicine’s Oncology products. Working together with the regulatory affairs team, this role will be a key contributor to several important regulatory filings. Prior experience with preparing IVD/medical device regulatory submissions is preferred.
What you will get to do :
- Author and support FDA submissions (including IDEs, pre-submissions, PMAs, 510(k)s, etc.) and other global submissions for Predicine’s Oncology products with guidance from the Regulatory Affairs Manager and other team members
- Prepare product-specific applications for CAP/CLIA/NYSDOH to support the company’s molecular testing business
- Maintain CLIA/CAP/state laboratory licensure to support Oncology and Infectious Disease product testing
- Support the extension of the Quality Management System (QMS) to prepare for regulatory filings
- Contribute to the regulatory team’s efforts to prepare regulatory documentation for various countries, including to support the use of Predicine’s diagnostic products in therapeutic trials
- Collaborate cross-functionally to support product development by ensuring compliance to global regulatory requirements and by supporting design change control activities
- Maintain knowledge of relevant global regulations and be able to interpret their impact to Predicine’s goals
- Demonstrate critical thinking, excellence, and speed when interacting with external partners and with regulatory authorities
- Ensure compliance with applicable global regulations
Qualifications/Skills/Experience
- Degree in a relevant scientific discipline
- Experience in preparation of regulatory submission packages or relevant technical documentation
- 1-2 years of experience in Regulatory Affairs, Quality Assurance, or a related technical role in IVD/medical device development
- Excellent written and verbal communication skills
- High quality standards and attention to detail when authoring and reviewing documents
- Able to distill complex issues and clearly articulate solutions
- Demonstrated learning agility to quickly grasp new concepts and apply them in an entrepreneurial environment
We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.
Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.