Lead Product Regulatory Strategist
Oracle
Lead Product Regulatory Strategist
Job Description
Overview
Oracle Health is seeking a Lead Product Regulatory Strategist to drive global regulatory strategies for our innovative health solutions in Dublin, Ireland. In this pivotal role, you will lead cross-functional teams to ensure compliance with international healthcare regulations and accelerate product market access. Join us to shape the future of healthcare technology at Oracle.
Responsibilities
- Develop and execute comprehensive regulatory strategies for Oracle Health products across EU and global markets.
- Lead interactions with regulatory authorities, including EMA, FDA, and national agencies, to secure approvals.
- Collaborate with R&D, product, and legal teams to integrate regulatory requirements into development lifecycles.
- Assess regulatory risks and provide strategic guidance on compliance for new product launches.
- Oversee preparation and submission of regulatory dossiers, including clinical data packages.
- Monitor evolving regulations (e.g., MDR, IVDR, GDPR) and advise on impacts to Oracle's portfolio.
- Mentor junior regulatory staff and build high-performing regulatory teams.
- Represent Oracle Health at industry conferences and regulatory working groups.
Qualifications
- 10+ years in regulatory affairs within healthcare/pharma/medtech, with 5+ years in leadership.
- Advanced degree in life sciences, pharmacy, law, or related field.
- Proven track record securing EU approvals (CE marking, notified body interactions).
- Deep knowledge of EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and GDPR.
- Strong strategic thinker with excellent communication and stakeholder management skills.
- Experience with SaaS/digital health regulatory pathways highly desirable.
Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous pension contributions and employee stock purchase plan.
- Flexible working arrangements with hybrid model in Dublin.
- Professional development budget and leadership training programs.
Locations
- DUBLIN, Ireland, IE
Salary
Skills Required
- Problem Solvingintermediate
- Communicationintermediate
Required Qualifications
- Bachelor's degree (experience)
- 7+ years experience (experience)
Preferred Qualifications
- Master's degree (experience)
- Enterprise experience (experience)
Responsibilities
- Design and develop solutions
- Collaborate with teams
- Participate in code reviews
- Troubleshoot issues
- Document implementations
Benefits
- general: Health Insurance
- general: 401(k)
- general: Stock Options
- general: PTO
Answer 10 quick questions to check your fit for Lead Product Regulatory Strategist @ Oracle.
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Lead Product Regulatory Strategist
Oracle
Lead Product Regulatory Strategist
Job Description
Overview
Oracle Health is seeking a Lead Product Regulatory Strategist to drive global regulatory strategies for our innovative health solutions in Dublin, Ireland. In this pivotal role, you will lead cross-functional teams to ensure compliance with international healthcare regulations and accelerate product market access. Join us to shape the future of healthcare technology at Oracle.
Responsibilities
- Develop and execute comprehensive regulatory strategies for Oracle Health products across EU and global markets.
- Lead interactions with regulatory authorities, including EMA, FDA, and national agencies, to secure approvals.
- Collaborate with R&D, product, and legal teams to integrate regulatory requirements into development lifecycles.
- Assess regulatory risks and provide strategic guidance on compliance for new product launches.
- Oversee preparation and submission of regulatory dossiers, including clinical data packages.
- Monitor evolving regulations (e.g., MDR, IVDR, GDPR) and advise on impacts to Oracle's portfolio.
- Mentor junior regulatory staff and build high-performing regulatory teams.
- Represent Oracle Health at industry conferences and regulatory working groups.
Qualifications
- 10+ years in regulatory affairs within healthcare/pharma/medtech, with 5+ years in leadership.
- Advanced degree in life sciences, pharmacy, law, or related field.
- Proven track record securing EU approvals (CE marking, notified body interactions).
- Deep knowledge of EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and GDPR.
- Strong strategic thinker with excellent communication and stakeholder management skills.
- Experience with SaaS/digital health regulatory pathways highly desirable.
Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous pension contributions and employee stock purchase plan.
- Flexible working arrangements with hybrid model in Dublin.
- Professional development budget and leadership training programs.
Locations
- DUBLIN, Ireland, IE
Salary
Skills Required
- Problem Solvingintermediate
- Communicationintermediate
Required Qualifications
- Bachelor's degree (experience)
- 7+ years experience (experience)
Preferred Qualifications
- Master's degree (experience)
- Enterprise experience (experience)
Responsibilities
- Design and develop solutions
- Collaborate with teams
- Participate in code reviews
- Troubleshoot issues
- Document implementations
Benefits
- general: Health Insurance
- general: 401(k)
- general: Stock Options
- general: PTO
Answer 10 quick questions to check your fit for Lead Product Regulatory Strategist @ Oracle.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs