Medical Device Regulatory Affairs Strategist
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Key skills for this role
About the Role
Oracle is seeking a Medical Device Regulatory Affairs Strategist to work with Oracle Health & Life Sciences business units. The role involves developing regulatory strategy for Middle East and Africa countries, managing submissions to health authorities, maintaining regulatory documentation, and supporting audits.
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
- 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
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
- Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries
- Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001
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 the 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 (Saudi Arabia), MOHAP (United Arab Emirates), MOPH (Qatar), NHRA (Bahrain), SAHPRA (South Africa), NAFDAC (Nigeria), EDA (Egypt) and PPB (Kenya).
- 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.
- 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 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.
- 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 in a dynamic environment.
Responsibilities (Detailed)
- 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 to identify, evaluate, disclose and appropriately remedy risks and deficiencies.
- Coordinates the preparation of and may prepare document packages for regulatory submissions.
- May serve as point of contact for interactions with regulatory agencies for defined matters.
- Support the creation of a comprehensive risk management and/or quality management, and regulatory oversight program.
- Review specifications.
- Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications.
- Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies.
- Identify industry requirements applicable to Oracle GBUs.
- Coordinate industry and regulatory certifications, including managing certification vendors.
- Build security documentation and collateral for customers and internal users.
- Build management level metrics and reporting for activities that are owned by the Risk Manager.
About Us
- Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life saving care.
- We’re committed to growing a workforce that promotes opportunities for all with competitive benefits.
- Oracle is an Equal Employment Opportunity Employer.
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