Senior Specialist, Regulatory Affairs & Quality - MedTech

Johnson & Johnson; Markham; Hybrid; CAD 85,000 - 110,000; Full time

Job summary

A leading healthcare company is seeking a Senior Specialist in Regulatory Affairs & Quality in Markham, ON. This role involves developing regulatory strategies for complex medical devices, managing product lifecycle processes, and mentoring junior specialists. Applicants should have a Bachelor’s degree in a relevant field, with at least five years of experience in medical device regulatory affairs. Strong documentation skills and experience with health authority inspections are essential. This is a fixed-term, hybrid position.

Qualifications

• Minimum of five years of experience in Medical Device and/or Pharmaceutical regulatory affairs.
• Strong documentation skills and technical writing capability.
• Proven ability to lead regulatory submission strategies.

Responsibilities

• Develop and execute Canadian regulatory strategies for Class III and IV medical devices.
• Manage regulatory aspects of the product lifecycle.
• Provide regulatory guidance to stakeholders.

Skills

Analytical Reasoning

Business Writing

Coaching

Collaborating

Communication

Problem Solving

Regulatory Compliance

Regulatory Affairs Management

Risk Assessments

Strategic Thinking

Education

University/Bachelor’s degree in Life Science, Engineering, or Physical Science

Post-graduate program in Quality/Regulatory Affairs

Tools

ISO 13485

ISO 9000 series

Lean

Six Sigma

Job description

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. Through 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 humanity. Learn more at https://www.jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

Markham, Ontario, Canada

Job Description

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Senior Specialist, Regulatory Affairs & Quality

We are searching for the best talent for a Senior Specialist, Regulatory Affairs & Quality to support our MedTech business. This role will work a Flex/Hybrid schedule and must be based within a commutable distance of Markham, ON. This is a Fixed Term role scheduled for a duration of 12 months from the date of hire. This role is ineligible for Severance at the conclusion of the term.

Responsibilities

• 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 JJMT 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 & vigilance) to enhance efficiency, compliance and overall performance.
• Leads or contributes to both local & 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 five (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.

#LI-Hybrid

Required Skills

Preferred Skills

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