Medical Device Regulatory Affairs Strategist
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Key skills for this role
About the Role
Seeking a regulatory affairs expert in medical devices to develop strategies, ensure compliance, and manage submissions across Middle East and Africa.
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 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 on interpretation of applicable standards, regulations, and 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
- Experience in regulatory affairs in the med tech space
- Knowledge of health authority regulations in Middle East and Africa (SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA, PPB)
- Experience with regulatory submissions and technical files
- Ability to develop regulatory strategy for medical devices
- Strong collaboration and communication skills
- Experience with quality management systems and audits
- Ability to interpret and apply standards and regulations
Full Job Posting
About the Role
- 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.
- To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast changing laws, regulations, and public policies across the globe.
- In this context, we are looking for regulatory affairs experts in the med tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector.
- You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries.
- This role requires an individual who can keep up with the fast paced environment of software development and an evolving regulatory landscape.
- For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work.
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.
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