At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Regulatory Affairs Group Regulatory Affairs Our

Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes.

The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. We are searching for the best talent for the Regulatory Affairs Specialis t in Markham, Ontario, Canada.

Develop and execute Canadian Regulatory strategies for complex Class III and Class IV medical devices, including combination products, to achieve and exceed business objectives.



Manage all Regulatory aspects of the product lifecycle from pre-market to post-marketing phase including reviewing and approving promotional material in alignment with corporate and Health Canada requirements.

Provide

Regulatory consultation for business partners and provide expert Regulatory guidance to all internal stakeholders. Establish and maintain robust relationships with Health Canada and business partners, driving collaboration on submission strategies, Regulatory pathways, submission status updates, recalls, and special access processes. Maintain and continuously improve the Quality Management System (QMS) at DePuy Synthes in accordance with Health Canada regulations and corporate requirements, covering critical Regulatory and quality processes (i.e. submission management, renewal, special access, distribution, CAPA, change controls, document/records management) to enhance efficiency, compliance and overall performance.

Participate and support preparation and execution of internal and external audits, including Health Canada and MDSAP inspections. Maintain awareness of new industry issues, trends and changes in regulation and policy and effectively communicate issues to key internal and external business partners. Coordinate comments on proposed regulations and policies.

University/Bachelor’s or equivalent degree in a Life Science, Engineering, or Physical Science is required. ~ Completion of post-graduate program in Quality/Regulatory Affairs is preferred.



~3 - 5 years of experience in Medical Device and/or Pharmaceutical / Biologics Regulatory Affairs is preferred. ~ Sound knowledge of Food and Drugs Act and Regulations and relevant policies and guidelines is required. ~ Experience In Managing Regulatory Submission Activities Is Required. ~ Strong Documentation Skills And Technical Writing Capability Is Required. ~ Experience in supporting health authority and or Notified Body inspections is an asset. ~ Proven ability to execute Regulatory submission strategies that align with business objectives and ensure compliance with applicable regulations is required. ~ Skills in managing change and implementation of new processes are preferred. ~ Experience in Quality system experience and strategic thinking in emerging and changing requirements preferred is an asset. ~ Experience in ISO 13485, or other Quality Systems Experience is an asset. ~ Experience in Canadian Regulatory Affairs for medical devices and combination products preferred.

Analytical

Reasoning, Business Writing, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking The expected base pay range for this position is $61,000.00 to $98,900.00 CAD. Under current guidelines, this position is eligible for a discretionary performance bonus. The Company uses Artificial Intelligence in its assessment of applicants.

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At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. #

📌 International Regulatory Specialist - Medical Devices (Remote) (Markham)
🏢 Brighter Signals
📍 Markham