At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Regulatory Affairs Group Regulatory Affairs About

Surgery Are you passionate about improving and expanding the possibilities of surgery? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer.

Your unique talents will help patients on their journey to wellness. We are searching for the best talent for an Associate Director, Surgery Regulatory Affairs to join our Canadian Surgery team. Reporting into the VP, Regulatory Affairs, Surgery International responsible for leading and executing regulatory activities to obtain and maintain RA registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures.

The Associate

Director, Regulatory Affairs, as a leader within the Canadian RA organization, develops and implements regulatory strategies to meet project deliverables. As a subject matter authority for Regulatory Affairs, provides guidance to local and global business partners. Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.





Support the building of a Regulatory Affairs talent pipeline through the selection and development of regulatory professionals, in partnership with regulatory leadership. Conduct analysis and risk assessment of pipeline projects, develop successful regulatory strategies to achieve desired business outcomes. Escalate as appropriate high-impact risks.

Lead the preparation and compilation of regulatory submissions for current and amended products, investigational testing and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products. Manage the preparation and review of responses to Health Canada queries in a timely manner. Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labelling and implementation of local regulatory strategies.

Collaborate with global regulatory teams to facilitate regulatory activities within the established global framework. Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities. Handle emerging issues and associated risk communications to stakeholders.

Provide regulatory guidance to internal collaborators on messaging and promotional material review. Monitor the regulatory environment, interpret changes,



analyze gaps and conduct impact assessments Influence and shape Health Canada policies to create a supportive regulatory environment for pipeline products. Minimum of a bachelor’s degree; science-related field of study is desired.

Minimum of 8 years relevant Regulatory Affairs or related experience is required. Solid understanding of laws, regulations, guidelines and policies related to medical technologies and processes for the review and approval of health product submissions required. Strong working knowledge of regulatory submission requirements required.

Up to 10% business travel may be required. Understanding of the application of laws, regulations, guidance’s and policies to specific projects. Ability to interpret and understand Regulations in the context of the scientific and commercial environment.

Ability to interpret, summarize and communicate clinical data. Well-developed project management skills and ability to manage multiple priorities. People supervisory and coaching skills. Excellent customer and marketplace focus.

The anticipated base pay range for this position is $139,750 to $189,750 CAD. Under current guidelines, this position is eligible for a discretionary performance bonus. 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. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

People

Leadership, Regulatory Affairs Management, Regulatory Submissions Analytical Review, Clinical Data Analysis, Clinical Data Review, Regulations #

📌 Associate Director, Surgery Regulatory Affairs | Markham, Ontario, Canada
🏢 Johnson u0026 Johnson MedTech
📍 Markham