Medical Device Regulatory Affairs Strategist
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Key skills for this role
About the Role
Oracle seeks a Medical Device Regulatory Affairs Strategist to lead regulatory strategy for Middle East and Africa. You will work with product engineering teams, manage submissions to health authorities, and ensure compliance.
Key Skills for This Role
Responsibilities
- 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 ensuring ongoing compliance
- 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, regulations, and use of the quality management system
- Manage regulatory and compliance related projects for Health related products
- Review and recommend changes to labeling, marketing materials, clinical protocols, design processes, and procedures to maintain regulatory and quality compliance
- Maintain compliance with changing regulatory requirements across global markets
- Build effective working relationships with regulatory agencies, affiliates, and cross functional stakeholders
Requirements
- 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 or equivalent
- 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
- Excellent written and verbal communication skills
Full Job Posting
Job Description
- At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. In thi
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 (Saudi Arabia), MOHAP (United Arab Emirates), MOPH (Qatar), NHRA (Bahrain), SAHPRA (South Africa), NAFDAC (Nigeria), EDA (Egypt) and PPB (Kenya) ensuring ongoing compliance with regulatory authoriti
- Maintain regulatory documentation, technical files, and post market surveillance activities ensuring ongoing compliance with applicable regulations.
- 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, regulations, and use of the quality management system.
- Manage regulatory and compliance related projects for Health related products.
- Review and recommend changes to labeling, marketing materials, clinical protocols, design processes, and procedures to maintain regulatory and quality compliance.
- Maintain compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs.
- Build effective working relationships with regulatory agencies, affiliates, and cross functional stakeholders to support aligned and practical regulatory outcomes.
Preferred Qualifications
- Bachelor’s degree in pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or a related field.
- Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions across assigned Middle East and Africa market required. Experience with sustaining and new product development is ideal.
- Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries, with demonstrated experience interpreting local regulations and supporting market access, lifecycle compliance, and health authority engagements.
- Strong problem solving, planning, and organizational skills, with the ability to manage multiple priorities and work independently in a fast paced, cross cultural environment.
- 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 in a dynamic environment.
- Ability to perform in a fast paced and continually evolving business environment.
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