Regulatory Affairs Director

Summary
We’re currently seeking a Regulatory Affairs Director for a small, yet exciting CRO focused on IVD clinical studies. This is a great opportunity to join a small team and make a big difference! The ideal candidate will have a deep understanding of IVD products and a proven track record of successful regulatory submissions in a CRO or similar environment. This position will be remote, full-time and reports to the Head of Clinical Research. Target salary is 190-202K

Responsibilities

• Lead the regulatory strategy and operations for IVD products, ensuring compliance with global regulatory requirements.
• Maintain and manage regulatory documentation and records accurately and efficiently.
• Develop and implement regulatory strategies tailored to the needs of each client and project.
• Oversee regulatory submissions, managing relationships with regulatory agencies, and guiding clients through the regulatory landscape.
• Leverage leadership abilities to mentor, guide, and manage teams across multiple regulatory projects, fostering a culture of accountability and continuous improvement.
• Collaborate with project managers, clinical teams, and other stakeholders to ensure regulatory requirements are integrated into project plans and timelines.
• Provide regulatory input into client product design, labeling, advertising, and promotional materials.
• Participate in risk management activities and ensure alignment with regulatory requirements for client projects.
• Stay abreast of regulatory changes and trends and communicate their impact to clients and internal stakeholders.
  

Education and Experience

• Bachelor’s degree in life sciences, engineering, or a related field required; advanced degree preferred.
• Minimum of 10 years of regulatory affairs experience in the IVD industry, with at least 5 years in a CRO or consulting environment required.
• Proven track record of successful regulatory submissions and interactions with regulatory authorities required.
• Extensive knowledge of IVD regulations (e.g., FDA 21 CFR Part 820, IVD Directive 98/79/EC, IVDR 2017/746, ISO 13485, ISO 14971).
• Expertise in global regulatory submission requirements (FDA, EMA, PMDA, TGA, etc.).
• Familiarity with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
• In-depth knowledge of regulatory submission processes for IVD devices, including: Premarket Notifications (510(k)) Premarket Approvals (PMA) Investigational Device Exemptions (IDE) and Conformity Assessments for CE Marking.
• Understanding of the IVD product lifecycle, from research and development through clinical trials, regulatory approval, and post-market monitoring.
• Familiarity with regulatory requirements related to clinical trials for diagnostics and analytical performance studies.
  

 

Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.  All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.