Associate, Regional Regulatory Affairs

About the job

The role closely works with distributors, service partners, and internal global regulatory teams to obtain and maintain product registrations and support commercial expansion.

Facilitate communication and coordination among internal stakeholders across different regions to obtain the necessary documentation required for global product registrations of externally manufactured devices.Oversee the end-to-end process of requesting and providing documentation, ensuring efficiency, accuracy, and compliance with regulatory requirements.Work closely with regional teams to gather and organize information, addressing queries promptly and fostering a collaborative environment for document retrievalPrepare reports for management review under the discretion of managerPerform other work-related duties as assigned, such as participation in process improvement initiatives. Internal Customers:

• Business Unit Regulatory Affairs: Regulatory strategy and submission alignment
• Commercial and Marketing Teams: Support product launches
• Supply Chain and Planning: Support importation, inventory, and continuity of supply

External Customers:

• Distributors and Service Partners
• Regulatory Consultants and Authorized Representatives
• Local Health Authorities and Industry Membership

Required Skills:

• Education: Bachelors degree in a scientific discipline (e.g. Pharmacy, Chemistry, Biology, Engineering or related). Advanced degree an asset (MSc, PhD).
• Experience: Minimum of one year of regulatory affairs experience in regulated industry (Medical Device, IVD, or Drugs).
• Technical Skills: Demonstrated knowledge of IVD Medical Device regulatory environments. Experience in operating within Quality Systems (ISO 9001, ISO 13485)
• Soft Skills: Strong project management, problem solving, communication, and negotiation skills. Demonstrated ability to work independently, proactively, and with an attention to details.
• Travel: Upto 5%
• Language: Fluent in English (advanced written and verbal comprehension)

Preferred Skills:

• Certificate in Quality Management or Regulatory Affairs
• Experience working with distributors and third-party regulatory consultants
• Familiarity with electronic document management systems and Microsoft Office Suite products (Excel, SharePoint, etc)Strong organizational and presentation skills