Senior Regulatory Affairs Specialist

• Develop, lead 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.
• Support internal and external audits for local and global business units
• Provide expert Regulatory guidance to internal stakeholders and mentor junior Regulatory Specialists and Associates to build team capability.
• 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.
• Maintains and continuously improves 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. distribution, supplier management, CAPA, change controls, document/records management complaint management and vigilance) to enhance efficiency, compliance and overall performance.
• Leads or contributes to both local and global strategic Regulatory or quality projects within the QMS and/or distribution workflows including process optimizations with a focus on digital and data-driven approaches
• Support preparation and execution of internal and external audits, including Health Canada and MDSAP inspections.
• Review and approve quality documentation, including SOPs, work instructions, and controlled records.

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 an asset.
• A minimum of 3 to 5 years of experience in Medical Device and/or Pharmaceutical / Biologics Regulatory Affairs.
• Proven experience in successfully collaborating across functions and delivering business results.
• Strong documentation skills and technical writing capability.
• Experience in managing health authority and or Notified Body inspections.
• Proven ability to lead and execute Regulatory submission strategies that align with business objectives and ensure compliance with applicable regulations.
• Excellent analytical and problem-solving skills, with the ability to effectively prioritize, organize, and manage multiple tasks.
• Skills in managing change and implementation of new processes.
• Excellent verbal and written communication skills.
• Experience in Quality system experience and strategic thinking in emerging and changing requirements preferred.
• Experience in implementing and maintaining Digital Quality Systems preferred.
• Experience in ISO 13485, ISO 9000 series, Lean, Six Sigma or other Quality Systems Experience an asset.
• Experience in Canadian Regulatory Affairs for medical devices and combination products preferred.

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.

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.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is :

$98,000.00 - $157,550.00

Additional 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)).

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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