Senior Director Regulatory Affairs – EMEA & Canada
Johnson & Johnson MedTech · Galway
Job description
About the role
The Senior Director Regulatory Affairs for EMEA and Canada leads the regional RA function, shaping regulatory strategy, guiding senior business leaders and ensuring product approvals across multiple markets.
Key responsibilities
- Lead regional RA teams to support business growth, accelerate product approvals and manage lifecycle and market access.
- Represent the regional RA organization in global and regional leadership discussions, providing market insights and driving strategic priorities.
- Develop and execute regional regulatory strategies that reflect country‑specific dynamics and align with global business objectives.
- Monitor regulatory changes, assess impact and direct appropriate actions to maintain product compliance.
- Build a diverse, capable regulatory workforce through recruitment, retention and talent development.
- Represent J&J MedTech strategies in external regulatory forums, trade associations and authority meetings.
- Advance regulatory operating model excellence by implementing scalable processes, digital tools and data‑driven transparency.
- Manage regional RA budget, ensuring activities are delivered on time and within financial targets.
Required profile
- Minimum 15 years of experience in a regulated industry with at least 3 years in people‑management roles.
- Bachelor’s degree required; advanced degree (MBA, medicine, engineering, science or law) preferred.
- Proven senior leadership experience influencing strategy at senior‑level executives.
- Track record of creating regional regulatory strategies that support business deliverables.
- Experience with medical devices and cardiovascular submissions across multiple regions is a plus.
- Strong budget and cost‑center management experience in a complex financial model.
- Excellent English communication skills; additional regional languages are welcomed.
What we offer
- Annual bonus linked to individual and company performance.
- Generous vacation, parental, bereavement, caregiver and volunteer leave.
- Well‑being reimbursement and programs supporting physical, mental and financial health.
- Service anniversary and recognition awards.
- Access to a range of insurance plans for employees and eligible dependents.
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Published 4 days ago
Expires 1 month from now
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Johnson & Johnson MedTech
Galway
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