Sr Regulatory Affairs Specialist

Duties & Responsibilities:

• Develop and execute regulatory strategies to support expansion across JPAC markets.
• Lead regulatory readiness for tenders, ensuring alignment with local compliance requirements.
• Support setup of legal entities, distributors, or economic operator structures in new markets.
• Interpret evolving regulatory requirements and translate them into actionable strategies for business teams.
• Collaborate closely with Sales and Commercial teams to support participation in regional tenders.
• Prepare and review regulatory documentation required for tender submissions (e.g., certificates, compliance statements, regulatory approvals).
• Develop regulatory memos, justifications, and gap assessments to demonstrate compliance where formal documentation may not exist.
• Ensure timely delivery of compliant documentation aligned with tender timelines.
• Manage and support submissions to health authorities across JPAC (e.g., CDSCO, PMDA, TGA, HSA, NMPA, etc.).
• Interface with government agencies and notified bodies for approvals and registrations.
• Support company registration and licensing as a distributor, importer, or economic operator in various jurisdictions.
• Maintain regulatory intelligence on regional authority expectations and processes.
• Work cross-functionally with Quality, Clinical, Supply Chain, and Commercial teams to support regulatory and quality initiatives.
• Participate in and lead regulatory workstreams within broader business or transformation projects.
• Ensure alignment between regulatory deliverables and business objectives.
• Track and manage deliverables using project management best practices.
• Support regulatory aspects of product lifecycle management, including renewals, variations, and market expansions.
• Review and assess regulatory impact of product, labeling, or design changes.
• Coordinate submission of regulatory updates and change notifications to applicable markets.
• Ensure global regulatory documentation is adaptable to local requirements.
• Review labeling and promotional claims to ensure compliance with local regulatory requirements.
• Provide regulatory guidance on permissible claims to support commercial strategies.
• Partner with internal stakeholders to update labeling and IFUs as needed.
• Ensure consistency and compliance of regulatory documentation across markets.
• Provide insights to help shape future tender strategies and maintain competitive positioning.
• Support proactive planning by anticipating regulatory trends and risks.
• Utilize regulatory and quality IT systems (e.g., eQMS, RIM systems) to maintain accurate and compliant records.
• Drive process improvements to enhance efficiency of regulatory operations.

Minimum & Preferred Qualifications and Experience:

• A minimum of 2 years of work experience in a medical device Class II/ III environment.
• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
• Advanced degree preferred
• 3-5+ years of regulatory affairs experience within the medical device or healthcare industry
• Strong experience supporting JPAC regulatory environments
• Proven experience with:
  • Regulatory submissions and approvals across multiple APAC countries
  • Government agency interactions and company registration processes
• Experience in setting up distributors, legal entities, or economic operator structures is highly preferred
• Strong understanding of JPAC regulatory frameworks (e.g., CDSCO, PMDA, TGA, HSA, NMPA)
• Expertise in regulatory documentation, submissions, and compliance requirements
• Proficiency in regulatory and quality IT systems (e.g., RIM, eQMS)
• Strong cross-functional collaboration and stakeholder management skills
• Ability to work in fast-paced, ambiguous environments with agility
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to influence without authority and drive alignment across teams
• High attention to detail and commitment to compliance