Overview In this role you lead regulatory guidance within the Global Regulatory team to support project teams and external partners. You act as the regulatory SME, shaping strategies for submissions and ensuring compliance with regulatory and business requirements. You will coordinate across internal resources, agencies, and consultants, and stay current with evolving regulations. You'll train the team and engage with external partners to enable successful product registrations and approvals.
Responsibilities- Provide regulatory guidance to project teams and external partners to support business goals
- Lead the regulatory core team and coordinate issue resolution with internal and external stakeholders
- Document regulatory strategies for product submissions
- Prepare U.S. Pre-Submission documents for NGS and/or PCR assays and facilitate FDA pre-submission meetings
- Prepare U.S. regulatory submissions (PMA, PMA supplement, 510(k for NGS/PCR assays
- Support EU CE/IVD Technical File work and global product registrations
- Assess regulatory implications for new or changed products
- Monitor new/revised regulations and communicate impacts to the team
- Conduct training to improve regulatory knowledge within the team
- Assist in updating internal policies and procedures
- Participate in meetings with potential external partners
- Stay informed on regulatory guidelines, inspection reports, and journals
Key requirements- B.Sc. or equivalent in Biology, Chemistry, bioengineering, or related science
- at least 5 years of IVD Regulatory Affairs experience
- Hands-on experience with 510(k), PMA, and PMA supplement submissions
- Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
- Ability to lead multiple projects and meet deadlines
- Strong communication and teamwork skills
- Capacity to communicate regulations to technical functions within the company
- Experience as the RA representative on project core teams
- strong communication
- teamwork
- leadership
- 510(k) submissions
- PMA and PMA supplements
- regulatory strategy development
