Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category:People Leader
All Job Posting Locations:Markham, Ontario, Canada
Job Description:About SurgeryFueled 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 interpret and understand Regulations in the context of the scientific and commercial environment.
- Ability to interpret, summarize and communicate clinical data.
- Well-defined problem solving and analytical skills with demonstrated ability to think strategically
- Strong negotiation and influencing skills.
- Well-developed project management skills and ability to manage multiple priorities.
- Strong communication skills, both verbal and written.
- Well-developed interpersonal, team and leadership skills to facilitate teamwork and problem-solving.
- 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.
Use of AI:- The Company uses AI in its assessment of applicants.
Job Vacancy:- This job posting is for an existing position.
Required Skills: People Leadership, Regulatory Affairs Management, Regulatory Submissions
Preferred Skills:Analytical Review, Clinical Data Analysis, Clinical Data Review, Regulations
