Regulatory Affairs Specialist

Johnson & Johnson Co.; Markham; On-site; CAD 61,000 - 99,000; Full time

Job summary

Johnson & Johnson in Markham, Ontario, Canada, is seeking a Regulatory Affairs Specialist to develop Canadian regulatory strategies for complex medical devices and manage lifecycle activities from pre-market to post-marketing. You will lead submissions, ensure Health Canada compliance, and guide internal stakeholders on regulatory pathways.

The role requires 3–5 years in Regulatory Affairs for medical devices or biologics, a life-science degree, and strong technical writing.

Qualifications

• 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.
• Excellent skills in verbal and written communication are required.
• Ability to develop and maintain strong working relationships with business partners and key stakeholders is required.
• Demonstrated leadership skills is required.
• Proven experience in successfully collaborating across functions and delivering business results is required.
• Strong documentation skills and technical writing capability is required.
• Detail-oriented and ability to align with business objectives 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.
• Analytical and problem-solving skills, with the ability to effectively prioritize, organize, and manage multiple tasks 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.

Responsibilities

• 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.

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 jnj.com.

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 Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Markham, Ontario, Canada

Job Description:

About Orthopaedics

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

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.

Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

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

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.

We are searching for the best talent for the Regulatory Affairs Specialist in

Markham, 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.

Excellent skills in verbal and written communication are required.

Ability to develop and maintain strong working relationships with business partners and key stakeholders is required.

Demonstrated leadership skills is required.

Proven experience in successfully collaborating across functions and delivering business results is required.

Strong documentation skills and technical writing capability is required.

Detail-oriented and ability to align with business objectives 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.

Analytical and problem-solving skills, with the ability to effectively prioritize, organize, and manage multiple tasks 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.

Preferred Skills:

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 Thinking

The expected base pay range for this position is $61,000.00 to $98,900.00 CAD.

Under current guidelines, this position is eligible for a discretionary performance bonus.

AI Usage Disclosure

The Company uses Artificial Intelligence in its assessment of applicants.

Vacancy Disclosure

This job posting is for an existing position.

Accessibility for Ontarians with Disabilities Act

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.