Medical Device Regulatory Affairs Strategist
Job Fit Check
Base Career helps you apply smarter for this job.
Key skills for this role
About the Role
Oracle is seeking a Medical Device Regulatory Affairs Strategist to drive regulatory strategy for health and life sciences products in the Middle East and Africa. The role involves working with product engineering teams, managing submissions to health authorities, and ensuring compliance with regulations.
Key Skills for This Role
Responsibilities
- Work closely with product engineering teams to assess product functionality and develop regulatory strategy for Middle East and Africa countries
- Collaborate cross functionally to create and manage submissions for health authorities
- Maintain regulatory documentation, technical files, and post market surveillance activities
- Support internal and external audits to identify and remedy risks and deficiencies
- Serve as subject matter expert for interpretation of standards and regulations
- Manage regulatory and compliance related projects for Health related products
- Review and recommend changes to labeling, marketing materials, and design processes
- Maintain compliance with changing regulatory requirements across global markets
Requirements
- Bachelor’s degree in Pharmacy, Biology, Biomedical Engineering, Life Sciences, or related field
- Experience in Regulatory Affairs, Quality Compliance, or Product Development in medical device industry
- Experience authoring submissions across Middle East and Africa markets
- Comprehensive knowledge of regulatory requirements across Middle East and Africa countries
- Experience with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001
- Excellent written and verbal communication skills
Full Job Posting
Job Description
- We are looking for regulatory affairs experts in the med tech space to play a key role in driving Oracle's success in healthcare and life sciences.
- You will work primarily with Oracle Health & Life Sciences business units.
What You’ll Do
- Work closely with Oracle’s product engineering teams to assess product functionality and develop regulatory strategy for Middle East and Africa countries.
- Collaborate cross functionally to create and manage submissions for health authorities including SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA and PPB.
- Maintain regulatory documentation, technical files, and post market surveillance activities.
- Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies.
- Serve as a subject matter expert for internal clients with interpretation of applicable standards and regulations.
- Manage regulatory and compliance related projects for Health related products.
- Review and recommend changes to labeling, marketing materials, clinical protocols, design processes, and procedures.
- Maintain compliance with changing regulatory requirements across global markets.
- Build effective working relationships with regulatory agencies, affiliates, and cross functional stakeholders.
Preferred Qualifications
- Bachelor’s degree in pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or a related field.
- Experience with SaMD in Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry.
- Experience authoring submissions across assigned Middle East and Africa market required.
- Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries.
- Strong problem solving, planning, and organizational skills.
- Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001.
- Understands continual improvement and risk management.
- Excellent written and verbal communication skills.
- Experience engaging with regional trade associations, industry groups, or regulatory forums.
- Ability to adjust and adapt to changing priorities.
Responsibilities (from description)
- Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance.
- Conducts and facilitates internal and external audits.
- Coordinates the preparation of document packages for regulatory submissions.
- May serve as point of contact for interactions with regulatory agencies.
- Support the creation of a comprehensive risk management and/or quality management program.
- Develop training for GBU development teams on industry regulatory specifications.
- Execute risk assessments and evaluate risks to the business.
- Identify industry requirements applicable to Oracle GBUs.
- Coordinate industry and regulatory certifications.
- Build security documentation and collateral for customers.
- Build management level metrics and reporting.
- Execute a vendor security and/or quality management program.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Oracle
Senior Solution Architect
Abu Dhabi, UAE
Oracle seeks a Senior Solution Architect to partner with clients on Oracle Health technologies, delivering solution configurations and application maintenance. The role involves troubleshooting, client engagement, and dr
Senior Solution Architect
Abu Dhabi, UAE
Oracle seeks a Senior Solution Architect to partner with clients on Oracle Health technologies, delivering solution configurations and application maintenance. The role involves troubleshooting, client engagement, and dr
Senior Solution Architect
Abu Dhabi, UAE
Oracle seeks a Senior Solution Architect to partner with clients on Oracle Health technologies, delivering solution configurations and application maintenance. The role involves troubleshooting, client engagement, and dr
Senior Solution Architect
Abu Dhabi, UAE
Oracle seeks a Senior Solution Architect to partner with clients on Oracle Health technologies, delivering solution configurations and application maintenance. The role involves troubleshooting, client engagement, and dr
CSS Account Executive
United Arab Emirates, UAE
Oracle is hiring a CSS Account Executive to drive services growth in the UAE territory. You will close business, manage renewals, build customer relationships, and identify upsell opportunities. Requires experience in sa
HR Intern
Saudi Arabia, KSA
We are seeking an ambitious intern eager to learn about Human Resources, to join our team to contribute with the HR team to daily HR administrative related tasks at Oracle Saudi...
CSS Account Executive
United Arab Emirates, UAE
What you will do: Contribute towards accelerating growth and exceeding customer expectations. Execution of Oracle Services strategy throughout the territory delivery of services...
HR Intern
Riyadh, KSA
Oracle Saudi seeks an ambitious HR intern to support daily HR administrative tasks including onboarding, record keeping, and compliance with local regulations. This 12-month internship requires Arabic and English fluency
Senior Solution Architect
Abu Dhabi, UAE
Senior Solution Architect
Abu Dhabi, UAE
Senior Solution Architect
Abu Dhabi, UAE
Senior Solution Architect
Abu Dhabi, UAE
CSS Account Executive
United Arab Emirates, UAE
HR Intern
Saudi Arabia, KSA
CSS Account Executive
United Arab Emirates, UAE
HR Intern
Riyadh, KSA