Senior Regulatory Affairs Specialist

Johnson & Johnson Innovative Medicine•Markham, ON

8d•CA$107,550 - CA$157,550•Onsite

About The Position

This role is for a Senior Specialist, Regulatory Affairs - MedTech, located in Toronto, Ontario. The purpose of this position is to help establish and implement compliance with regulatory agency regulations by providing advanced knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements. This role involves analyzing and interpreting scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market. The company is Johnson & Johnson, specifically within their Orthopaedics division, which is in the process of becoming a standalone company named DePuy Synthes. The role is within the Regulatory Affairs Group and is categorized as Professional.

Requirements

University/Bachelor’s or equivalent degree in a Life Science, Engineering, or Physical Science is required.
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.

Nice To Haves

Completion of post-graduate program in Quality/Regulatory Affairs is an asset.
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.

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 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.