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. The role involves working with product engineering, managing submissions to health authorities, and ensuring compliance.
Key Skills for This Role
Responsibilities
- Work with product engineering teams to assess product functionality and develop regulatory strategy for Middle East and Africa countries.
- 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 and remedy risks and deficiencies.
- Serve as subject matter expert for interpretation of applicable standards and regulations.
- Manage regulatory and compliance projects for health related products.
- Review and recommend changes to labeling, marketing materials, clinical protocols, and design processes.
- Maintain compliance with changing regulatory requirements across global markets.
- Build effective working relationships with regulatory agencies and cross functional stakeholders.
Requirements
- Bachelor's degree in Pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or related field
- Experience in Regulatory Affairs, Quality Compliance, or Product Development in medical device industry
- Experience authoring submissions for 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
Full Job Posting
Job Description
- At a time of rapid technological and regulatory change, success of global health companies requires regulatory leaders who can navigate complex laws and policies.
- We are looking for regulatory affairs experts in the med tech space to drive Oracle's success in healthcare and life sciences.
What You’ll Do
- Work 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 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 remedy risks and deficiencies.
- Serve as subject matter expert for interpretation of applicable standards, regulations, and quality management system.
- Manage regulatory and compliance 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 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.
- 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 (Generic)
- 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 preparation of document packages for regulatory submissions.
- May serve as point of contact for interactions with regulatory agencies.
- Support creation of comprehensive risk management and/or quality management program.
- Review specifications and develop training for GBU teams.
- Execute risk assessments and develop risk mitigation strategies.
- 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.
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