Associate Director, Surgery Regulatory Affairs - Markham, Ontario, Canada

Johnson Johnson; Markham; On-site; CAD 140,000 - 190,000; Full time

Job summary

Johnson & Johnson in Markham, Ontario, is seeking an Associate Director, Surgery Regulatory Affairs to lead regulatory activities for Canada's surgical portfolio. You will report to the VP, Regulatory Affairs, Surgery International, and guide a team of professionals across local and global partners to secure Health Canada approvals and maintain product registrations.

The role requires a bachelor’s degree in a science field, 8+ years in regulatory affairs, strong knowledge of Health Canada

Qualifications

• Bachelor's degree in a science-related field (preferred).
• Minimum 8 years in Regulatory Affairs or related area.
• Strong working knowledge of medical device and health product submission requirements.
• Previous people leadership experience required.
• Up to 10% travel may be required.

Responsibilities

• Lead and mentor a group of regulatory professionals to deliver objectives with local and global teams.
• Develop regulatory strategies and assess pipeline projects and risks.
• Prepare and compile regulatory submissions for Health Canada and manage product lifecycle.
• Coordinate responses to Health Canada queries in a timely manner.
• Collaborate with global regulatory teams within the established framework.
• Align regulatory strategy with business priorities.
• Build relationships with internal partners and opinion leaders as needed.
• Monitor regulatory environment and assess impact.
• Influence Health Canada policies to support pipeline products.
• Improve departmental processes and work environment.

Skills

Regulatory leadership

Regulatory affairs

Health Canada submissions

Regulatory strategy

Cross-functional collaboration

People leadership

Risk assessment

Travel readiness

Education

Bachelor's degree in science or related field

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:

People Leader

All Job Posting Locations:

Markham, Ontario, Canada

About Surgery

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 surgery? Ready to join a team that's reimagining how we heal? 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. Patients are waiting.

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

We are searching for the best talent for an Associate Director, Surgery Regulatory Affairs to join our Canadian Surgery team. This position is based in Markham, Ontario, Canada.

Purpose:

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.

You will be responsible for:

• 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 new 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.
• Develop effective working relationships with business partners as well as opinion leaders as needed.
• 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.
• Actively contribute to improving critical departmental processes and initiatives to enhance the internal work environment.

Qualifications:

Required:

• 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.
• Previous people leadership experience is required.
• Up to 10% business travel may be required.

Preferred:

• Understanding of the application of laws, regulations, guidance's and policies to specific projects.
• Ability to