1 день назад
Associate Director, Surgery Regulatory Affairs (MedTech)
139 750 - 189 750CAD
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Surgery Regulatory Affairs (MedTech): Leading Canadian regulatory strategies and submissions for surgical technologies with an accent on Health Canada compliance, product lifecycle management, and people leadership. Focus on assessing pipeline risks, managing responses and review-cycle interactions, and influencing regulatory policies for new and amended health products.
Location: Hybrid position based in Markham, Ontario, Canada; up to 10% business travel may be required.
Base pay: CAD 139,750–189,750 per year, plus eligibility for a discretionary performance bonus.
Company
Johnson & Johnson MedTech develops surgical technologies and healthcare solutions designed to make treatments smarter, less invasive, and more personalized.
What you will do
- Lead and mentor Canadian regulatory professionals and support the development of the regulatory talent pipeline.
- Develop regulatory strategies, analyze pipeline risks, and escalate high-impact issues.
- Prepare and maintain regulatory submissions for new, amended, investigational, and marketed products submitted to Health Canada.
- Manage responses to Health Canada queries and lead interactions throughout the submission review cycle.
- Collaborate with global regulatory teams and internal business partners to align regulatory strategies with business priorities.
- Monitor regulatory changes, conduct impact assessments, advise on promotional materials, and support risk communications.
Requirements
- Bachelor’s degree required; a science-related field is preferred.
- At least 8 years of relevant Regulatory Affairs or related experience.
- Strong knowledge of laws, regulations, guidelines, policies, and submission requirements for medical technologies and health products.
- Previous people leadership experience, including supervisory and coaching capabilities.
- Strong analytical, strategic, negotiation, influencing, communication, interpersonal, and project management skills.
Nice to have
- Experience interpreting and communicating clinical data.
- Experience applying regulations to specific projects and understanding scientific and commercial contexts.
- Customer and marketplace focus.
Culture & Benefits
- Inclusive work environment focused on employee dignity, diversity, and individual contribution.
- Opportunity to contribute to surgical technologies addressing obesity, cardiovascular disease, and cancer.
- Discretionary performance bonus eligibility.
- AI is used in the applicant assessment process.
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