Regulatory Affairs Associate

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Job Description

Stefanini Inc. (Stefanini) is a global technology company providing a full-service of onshore, nearshore, and offshore services; systems integration/development and consulting; and strategic staffing services to Fortune 1,000 enterprises worldwide. Stefanini is a leader in Workplace Services, Infrastructure Outsourcing, Application Services, and BPO. We work with our Customers to digitally transform their business for todays dynamic environment.

Today, Stefaninis global presence spans across four (4) continents, 41 countries with 70 offices and more than 38,000 employees speaking 44 languages.

Job Requirements

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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 (MDELs) and Drug Establishment Licenses (DELs).
• 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.
  
  

• Bachelors or higher Degree in Biomedical Engineering/Mechanical Engineering or a masters 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.
  
  

• 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.