Associate Director, RA Canada
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Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. 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:
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 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 Canadalocatedin Toronto Ontarioor US locations of Raynham MA Warsaw IN or West Chester PA
Job Overview
The Associate Director RA Canadaprovides regulatory leadership for the Canadian market ensuring compliance with local regulatory requirements while enablingtimelyand sustainable market access for DePuy Synthes products. This role plays a critical leadership position within theRegulatoryorganization 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 regulatoryobjectives.
Ensure compliance with Health Canada requirements internal policies and quality system standards.
Providestrategic 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 crossfunctional 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.
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:
Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline (required).
Advanced degree or professional certification in Regulatory Affairs (preferred).
Experience and Skills:
Required:
Typically810 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 decisionmaking skills.
Ability tooperateeffectively in a global matrixed organization.
Preferred:
Experience supportingUSor global regulatory operating models.
Experience working in multinational medicaldeviceor 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; Frenchproficiencypreferred.
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.
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 internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
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 :
$124000.00 - $212750.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Companys 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: - Experience:
Director
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
