Regulatory Affairs Associate

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Key Responsibilities:

. Perform regulatory screening of new products (including medical devices, PPE, Cosmetics, and pharmaceuticals) to ensure compliance with Health Canada requirements.

. Screen custom pack components to ensure compliance with Health Canada requirements.

. Manage and requisition of regulatory and quality documents, maintaining accuracy and timely access for stakeholders.

. Assist in the preparation and submission of medical device license applications and support amendments and renewals of Medical Device Establishment Licenses (MDEL's) and Drug Establishment Licenses (DEL's).

. Should I be able to make decisions and execute documentation requirements/requests as per the defined procedure.

. Should have the ability to contact appropriate personnel within Medline proactively and independently.

Must Have:

. Bachelor's or higher Degree in Biomedical Engineering/Mechanical Engineering or a master's degree in pharmacy with specialisation in Quality Assurance.

. 1-3 years of experience in the medical device or healthcare industry with a strong quality background.

. Basic knowledge of product classification under Health Canada, particularly for medical devices.

. Familiarity with the medical device license application process for Canada market.

. Proficiency in Microsoft Excel, with intermediate-level skills.

. Demonstrates excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders, ensuring alignment and understanding.

. Demonstrates a strong focus on outcomes by setting clear goals, taking ownership, and consistently delivering high-quality results that align with business objectives.

Good to Have:

. Experience or exposure to drug and Natural Health Product (NHP) submissions for Canada market.

. Understanding of Medical Device Establishment Licenses (MDEL), Drug Establishment Licenses (DEL), and site licenses for Canada market.

. Detail-oriented mindset with strong organisational skills to manage multiple projects and deadlines

. Analytical skills to interpret and apply regulatory requirements effectively.

. Experience with Rimsys, SAP, EtQ Reliance or any QMS software.

. Strong analytical abilities with attention to detail, thoughtful in considering all aspects of the problem and potential solutions

. Ability to work independently and in a global team environment.

. Good team player - Collaborates proactively across cross-functional teams and departments, driving alignment and contributing to high-impact, team-driven outcomes.

Working Hours:

11.30 am to 8.30 pm