Regulatory Affairs Associate

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...