Regulatory Specialist

Bring more to life.

In this role, you will have the opportunity to:

• Lead and manage product registration activities across South Asian countries by ensuring compliance with country-specific regulatory requirements, while monitoring regulatory status, submission timelines, and post-market requirements in the region.
• Prepare, compile, and review regulatory dossiers, applications, and technical documentation for Radiometer medical devices, IVDs and software products.
• Collaborate with regulatory consultants, distributors, and health authorities to facilitate smooth submissions and responses.
• Track and analyze local regulatory changes, maintain registration databases, and ensure compliance of labeling, packaging, and promotional materials with local requirements, while providing internal updates and supporting audits
• Collaborate with Product Regulatory, Quality, Supply Chain, and Commercial teams to support market entry strategies, ongoing compliance, and product lifecycle management activities including handling registrations for countries like Canada and the EU.
  

The essential requirements of the job include:

• Bachelor’s or master’s degree in life science, Engineering, Pharmacy, Biology, Biochemistry related filed
• Over 10 years of regulatory affairs experience in the medical device, IVD, or pharmaceutical industry, with specific expertise in South Asian markets, including knowledge of CDSCO, Import License Class A–D (India), DGDA (Bangladesh), NMRA (Sri Lanka), and Health Canada regulations.
• Skilled in managing multiple projects independently, coordinating with diverse stakeholders, and applying ISO 13485 and ISO 14971 standards, with familiarity in EU MDR, IVDR, and FDA frameworks.
• Proficiency in preparing and submitting technical files, registration dossiers, and XML-based submissions, with advanced knowledge of MS Office and Adobe Acrobat.
• Experience working with distributors in South Asia, providing regulatory guidance and support.
  

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel – list specifics % travel, overnight, within territory or locations
• Must have a valid driver’s license with an acceptable driving record
• Ability to lift, move or carry equipment up to ##lb, any other physical requirements
  

It would be a plus if you also possess previous experience in:

• Experience with regulatory submissions, including FDA 510(k) and EU MDR/IVDR Technical Files.
• Involvement in pre-market or post-market audits by CDSCO or Notified Bodies.
• Proficient in UDI, GUDID, and conducting international regulatory assessments for medical device design changes.