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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Toronto, Ontario, Canada, West Chester, Pennsylvania, United States of AmericaJob Description:
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. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.DePuy Synthes is recruiting for a(n) Associate Director, RA Canada, located in Toronto, Ontario or US locations of Raynham, MA, Warsaw, IN or West Chester, PA
Job Overview
The Associate Director, RA Canada provides regulatory leadership for the Canadian market, ensuring compliance with local regulatory requirements while enabling timely and sustainable market access for DePuy Synthes products. This role plays a critical leadership position within the Regulatory organization, partnering with commercial, quality, and global regulatory teams to shape regulatory strategy, manage risk, and support business growth in a highly regulated environment.
Key Responsibilities
Lead and oversee regulatory affairs strategy and execution for the Canada local market in alignment with global regulatory objectives.
Ensure compliance with Health Canada requirements, internal policies, and quality system standards.
Provide strategic regulatory guidance to support product registrations, renewals, variations, and lifecycle management.
Serve as the senior regulatory point of contact and escalation lead for Canada Local Market Support.
Partner with cross‑functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.
Monitor regulatory changes in Canada and assess potential impacts to products, portfolios, and operations.
Support regulatory inspections, audits, and health authority interactions as required.
Lead, coach, and develop regulatory talent, fostering strong compliance, accountability, and performance.
Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Qualifications
Education:
Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
Advanced degree or professional certification in Regulatory Affairs (preferred).
Experience and Skills:
Required:
Typically 8–10 years of progressive experience in Regulatory Affairs within the medical device or other regulated industries.
Strong knowledge of Canadian regulatory requirements and Health Canada processes.
Demonstrated experience leading regulatory strategy and execution at the country level.
Proven ability to manage regulatory risk and complex stakeholder environments.
Strong leadership, communication, and decision‑making skills.
Ability to operate effectively in a global, matrixed organization.
Preferred:
Experience supporting US or global regulatory operating models.
Experience working in multinational medical device or healthcare organizations.
Exposure to regulatory inspections, audits, and authority negotiations.
Demonstrated success driving regulatory transformation or process improvement initiatives.
Regulatory Affairs Certification (RAC) or equivalent.
Other:
Language: English required; French proficiency preferred.
Travel: Moderate national travel; occasional international travel. If based in a US location, 50% travel could be expected
Certifications: RAC or equivalent preferred but not required.
Johnson & Johnson is an Equal Opportunity 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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic ThinkingThe anticipated base pay range for this position is :
$124,000.00 - $212,750.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson Guelph, Ontario, CAN Office
890 Woodlawn Rd W, Guelph, Ontario, Canada, N1K 1A5
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