Regulatory Affairs

About the role

Our client, a leader in the Pharmaceuticals & Biotech space, is seeking a Regulatory Affairs professional to support global product compliance for a regulated diagnostics portfolio. The role focuses on international market access and submission strategy, monitoring evolving regulations, translating requirements into operational action, and ensuring appropriate documentation for compliant commercialization. The position works closely with cross‑functional teams to embed regulatory considerations into product development and lifecycle activities. This position is remote, U.S.‑based candidates only; no visa sponsorship is available.

Responsibilities

• Ensure global product compliance with regulatory requirements for an IVD portfolio.
• Support regulatory submissions for product marketing in multiple international markets.
• Monitor evolving global regulations and assess their operational impact.
• Compile and maintain essential regulatory technical documentation for compliance.
• Collaborate with cross‑functional teams to integrate regulatory requirements into product development.

Qualifications

• Bachelor's degree or equivalent experience.
• Minimum of three years of experience in the regulated medical device, IVD, or a related industry.
• Strong knowledge of international submissions across LATAM, the EU, Asia, and MDSAP countries.
• Experience with antibody‑based diagnostics is strongly preferred.
• Excellent leadership, communication, and project management skills.
• Familiarity with eQMS platforms such as MasterControl, Veeva Vault, or AssurX is highly desirable.

Benefits

• Option to work remotely.
• Participation in company‑wide regulatory compliance training.
• Engagement in continuous improvement initiatives for regulatory processes.

Pay

Compensation ranges from $104,774 to $163,710 annually.