About this opportunityAt 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.Job Function:Regulatory Affairs GroupJob Sub Function:Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Markham, Ontario, Canada:About OrthopaedicsFueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.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. Learn more at &

• 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 Specialist inMarkham, Ontario, Canada.You will be responsible for: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 strong 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.Qualifications / Requirements: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 ThinkingJohnson &

• Johnson is an Equal Chance Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.**

📌 International Regulatory Specialist - Medical Devices (Remote) (Markham)
🏢 Biopharma Careers
📍 Markham