Medical Device Regulatory Affairs Strategist

Role overview

This position is for a regulatory affairs specialist focused on medical technology and health-related products within a global software and healthcare environment. The role supports the healthcare and life sciences business and works across product teams to help ensure products, processes, and documentation stay aligned with evolving laws and standards across multiple markets.

The work is centered on regulatory strategy, compliance, quality oversight, and market access across the Middle East and Africa. The right person will be comfortable operating in a fast-moving environment where software development and regulatory expectations change quickly, and will bring a collaborative, solutions-oriented approach.

Key duties

• Partner with product engineering teams to review product capabilities and shape regulatory strategy for countries in the Middle East and Africa region.
• Work across functions to prepare and manage regulatory submissions for authorities such as SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA, and PPB, while maintaining ongoing compliance.
• Keep regulatory records, technical files, and post-market surveillance activities current and compliant.
• Assist with internal and external audits, helping to identify risks, expose gaps, and support corrective action.
• Act as a subject matter resource for internal stakeholders on standards, regulations, and the use of the quality management system.
• Handle regulatory and compliance projects for healthcare-related products.
• Review and advise on labeling, promotional content, clinical protocols, design workflows, and procedures to protect regulatory and quality compliance.
• Track changing rules across global markets and adjust compliance activities as needed.
• Develop working relationships with regulators, affiliates, and cross-functional teams to reach practical and aligned regulatory outcomes.
• Assess internal operations, controls, communication, risk reviews, and records management, then recommend improvements where needed.
• Coordinate and support the preparation of submission packages and inspection/audit documents.
• Serve as a contact point for specific regulatory agency interactions when assigned.
• Support the development of a broad risk management, quality management, and regulatory oversight program.
• Review specifications and create training for development, cloud services, services, and operations teams on applicable regulatory expectations.
• Perform risk assessments, define mitigation plans, and help integrate industry standards, security policies, quality policies, and customer contractual requirements into team processes.
• Coordinate certification efforts and manage certification vendors such as PCI, HIPAA, HITECH, ISO, and SOC2.
• Develop security-related documentation and customer/internal collateral that strengthens the business value of security.
• Create management metrics and reporting for risk-related activities.
• Operate vendor security and/or quality management activities.

Preferred background

This role is aimed at professionals with a bachelor’s degree in a relevant scientific, engineering, biomedical, pharmacy, health sciences, or related discipline. Strong experience in software as a medical device, regulatory affairs, quality compliance, or product development is important, especially with submissions across Middle East and Africa markets.

Strong knowledge of regional regulatory pathways, lifecycle compliance, health authority engagement, and market access is expected. Familiarity with quality management systems and standards such as ISO 13485, ISO 14971, 60601, 62304, and 21 CFR parts 1000/1001 is preferred. The role also calls for excellent communication, risk management awareness, continual improvement mindset, and the ability to work independently while juggling multiple priorities in a multicultural environment.

Additional requirements and context

The position is designated at Career Level IC4. It sits within a large global technology environment where the business supports healthcare, life sciences, cloud services, and security-related programs. The organization emphasizes inclusion, accessibility, equal employment opportunity, and employee well-being through medical, life insurance, retirement options, and volunteer opportunities.

Accessibility support is available for candidates who need accommodation during the employment process.

Equal opportunity statement

All qualified candidates are considered without discrimination based on race, color, religion, sex, national origin, sexual orientation, gender identity, disability, veteran status, or other protected characteristics. Employment decisions also follow applicable laws regarding arrest and conviction records.