Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group
Oracle
Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group
Job Description
Overview
Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions for healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. The Medical Device Regulatory Affairs Strategist will drive regulatory compliance strategies for medical device solutions within the Health & Life Sciences Legal and Compliance Group. Based in London, this role ensures innovative products meet global standards while supporting business growth.
Responsibilities
- Develop and execute regulatory strategies for medical device software and hardware integrations.
- Collaborate with cross-functional teams to ensure compliance with EU MDR, FDA, and global regulations.
- Prepare and submit regulatory dossiers, technical files, and clinical evaluation reports.
- Monitor regulatory changes and advise on impacts to Oracle's Health & Life Sciences portfolio.
- Lead interactions with notified bodies, competent authorities, and regulatory agencies.
- Conduct gap analyses and risk assessments for product compliance.
- Support product launches by providing regulatory approval pathways and timelines.
- Mentor junior staff and contribute to continuous improvement of compliance processes.
Qualifications
- Advanced degree in life sciences, engineering, or related field; regulatory affairs certification (RAPS or equivalent) preferred.
- 7+ years of experience in medical device regulatory affairs, with focus on software/SaMD.
- Deep knowledge of EU MDR, IVDR, FDA 510(k)/PMA, and ISO 13485 standards.
- Proven track record of successful regulatory submissions and approvals.
- Strong analytical, communication, and stakeholder management skills.
- Experience in Health & Life Sciences or medtech industry; ability to work in fast-paced environment.
Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous pension scheme and employee stock purchase plan.
- Flexible working arrangements and 25+ days annual leave.
- Professional development opportunities and career growth in global leader.
Locations
- LONDON, United Kingdom, GB
Salary
Responsibilities
- Work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device)
- Help prepare the required documentation to register products in global markets where the products are sold
- Establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope
- Work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable
Benefits
- general: Health Insurance
- general: 401(k)
- general: Stock Options
- general: Flexible PTO
Answer 10 quick questions to check your fit for Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group @ Oracle.
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Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group
Oracle
Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group
Job Description
Overview
Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions for healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. The Medical Device Regulatory Affairs Strategist will drive regulatory compliance strategies for medical device solutions within the Health & Life Sciences Legal and Compliance Group. Based in London, this role ensures innovative products meet global standards while supporting business growth.
Responsibilities
- Develop and execute regulatory strategies for medical device software and hardware integrations.
- Collaborate with cross-functional teams to ensure compliance with EU MDR, FDA, and global regulations.
- Prepare and submit regulatory dossiers, technical files, and clinical evaluation reports.
- Monitor regulatory changes and advise on impacts to Oracle's Health & Life Sciences portfolio.
- Lead interactions with notified bodies, competent authorities, and regulatory agencies.
- Conduct gap analyses and risk assessments for product compliance.
- Support product launches by providing regulatory approval pathways and timelines.
- Mentor junior staff and contribute to continuous improvement of compliance processes.
Qualifications
- Advanced degree in life sciences, engineering, or related field; regulatory affairs certification (RAPS or equivalent) preferred.
- 7+ years of experience in medical device regulatory affairs, with focus on software/SaMD.
- Deep knowledge of EU MDR, IVDR, FDA 510(k)/PMA, and ISO 13485 standards.
- Proven track record of successful regulatory submissions and approvals.
- Strong analytical, communication, and stakeholder management skills.
- Experience in Health & Life Sciences or medtech industry; ability to work in fast-paced environment.
Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous pension scheme and employee stock purchase plan.
- Flexible working arrangements and 25+ days annual leave.
- Professional development opportunities and career growth in global leader.
Locations
- LONDON, United Kingdom, GB
Salary
Responsibilities
- Work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device)
- Help prepare the required documentation to register products in global markets where the products are sold
- Establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope
- Work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable
Benefits
- general: Health Insurance
- general: 401(k)
- general: Stock Options
- general: Flexible PTO
Answer 10 quick questions to check your fit for Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group @ Oracle.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs