Gilbert Meher are exclusively partnered with an early stage Molecular Diagnostics company who have developed an innovative portfolio of reagents within the Oncology space. This rapidly growing company are seeking a Regulatory Affairs Manager to lead the company in its transition from RUO to IVD certification.
This is a unique opportunity to join a company as they plan to move their comprehensive genomics portfolio towards IVD and CLIA certification. Reporting directly to the SVP QA RA, the successful individual will lead a team that spearheads this regulatory change, creating and implementing new regulatory strategies that align with corporate goals.
- Provide hands-on leadership in the preparation and submission of regulatory submissions – either for 510(k) or PMA approval.
- Develop and implement Regulatory SOPs, working cross-functionally to ensure continued regulatory compliance throughout the business.
- Lead training programs to existing product development teams, ensuring best-in-class regulatory thinking surrounding product development processes.
- Continuously liaise with regulatory agencies to ensure continued development compliance and quickly resolve any issues.
- Contribute to ISO 9001 projects, providing continued regulatory advice to ensure compliance in a currently research-focussed organisation.
- Work alongside the SVP RA & QA to establish budgeting, resource allocation and priority setting.
- Keep up to date with global regulatory changes and implement changes to existing internal policies as required.
- Provide end-to-end leadership on all regulatory submissions, ensuring timeliness, accuracy and comprehensiveness that ultimately lead to the successful approval of IVD products.
- Establish and implement internal systems to ensure all regulatory policy is kept up to date and maintained throughout the business.
- Work cross-functionally with commercial teams to review marketing materials to ensure compliance.
- BSc minimum required, with additional qualifications in Regulatory Affairs preferred.
- >3 years’ industrial experience within Life Sciences/Medical Devices required.
- Proven track-record of IVD submissions, with multiple examples of core-team submission experience.
- Experience writing and submitting files for 510(k)/PMA required.
- Demonstrated experience in leading/mentoring/training individuals on regulatory procedures.
- Stage-gate product development process experience a strong preference.
- Driven to work in a growing company environment.
This position is to be based in Houston, Texas at the company headquarters, and relocation will be supported. Please note, there is potential to increase the seniority of this position to the Director level for the right amount of experience.
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.