Job Description
Key Areas of Responsibility:
Translates regulatory intelligence into actionable local, regional, and global regulatory strategies aligned with business goals.
Anticipates regulatory risks and emerging issues, offering proactive, solutions‑oriented guidance throughout the product lifecycle.
Evaluates products for classification, jurisdiction, and market‑access requirements, identifying the most efficient regulatory pathways.
Provides technical regulatory input across quality, preclinical, clinical, and manufacturing teams to ensure compliance.
Leads regulatory submissions end‑to‑end—planning, preparing, submitting, and managing interactions with global health authorities.
Reviews scientific documentation (quality, preclinical, clinical) for completeness, accuracy, and regulatory acceptability.
Collaborates effectively with cross-functional teams, supporting meetings with regulatory authorities and advisory committees.
Develops and enhances regulatory SOPs, strengthens compliance, and trains stakeholders on evolving regulatory expectations.
Manages complex regulatory projects with autonomy, strong organization, and sound decision‑making.
Demonstrates inclusive leadership, embracing diverse perspectives and supporting the development of Specialists/Sr. Specialists.
Adapts to challenging assignments, navigates organizational dynamics, and continuously builds regulatory expertise.
Qualifications
- Bachelor’s degree in Engineering, Science, or related field; Master’s in Regulatory Science preferred
- 4+ years of regulatory affairs experience in healthcare, medtech, pharma, or related regulated industries
- Regulatory Affairs Certification (RAC) is a plus
- Strong understanding of regulatory pathways, compliance, submissions, quality systems, and post‑market requirements
- Excellent communication, technical writing, and project management skills
- Ability to operate with autonomy, judgment, and cross‑functional influence