Medical Device Regulatory Affairs Strategist
Oracle
Quick Take
Develop and execute medical device regulatory strategies for Oracle's health software across MEA markets, managing submissions to health authorities and ensuring compliance with evolving regional standards.
5+ years of hands-on medical device regulatory experience across MEA jurisdictions, mastery of ISO 13485/IEC 62304 and SaMD frameworks, and ability to lead independent submissions across product and engineering teams.
High-impact role at a global tech leader with competitive salary (KES 350–600k/mo), exposure to cutting-edge health IT regulation, and strategic influence across an entire region's product roadmap.
Job Description
Oracle's Health & Life Sciences division is seeking a seasoned Medical Device Regulatory Affairs Strategist to help shape and execute regulatory strategy across the Middle East and Africa region. At a time when healthcare technology regulations are evolving at an unprecedented pace, this role sits at the intersection of software innovation and medical device compliance — requiring someone who can translate complex global regulatory frameworks into actionable product strategies.
You will serve as a critical bridge between Oracle's product engineering teams and health regulatory authorities across the MEA region, including Kenya's PPB, South Africa's SAHPRA, Nigeria's NAFDAC, and several Gulf-region bodies. This is a high-impact, cross-functional role that demands both deep regulatory expertise and the agility to thrive in a fast-paced software development environment.
- Partner closely with Oracle's product engineering teams to assess product functionality and develop regulatory strategies for Middle East and Africa markets.
- Prepare, manage, and submit regulatory dossiers to health authorities including SFDA (Saudi Arabia), MOHAP (UAE), MOPH (Qatar), NHRA (Bahrain), SAHPRA (South Africa), NAFDAC (Nigeria), EDA (Egypt), and PPB (Kenya).
- Maintain comprehensive regulatory documentation, technical files, and post-market surveillance records in full compliance with applicable regional and international regulations.
- Support internal and external audits, helping to identify, evaluate, disclose, and remediate regulatory risks and compliance deficiencies.
- Act as internal subject matter expert on applicable standards, regulations, and quality management systems for health-related software and devices.
- Lead and manage regulatory and compliance projects for health-related digital products and SaaS platforms.
- Review labeling, marketing materials, clinical protocols, and design processes to ensure sustained regulatory compliance.
- Monitor and interpret evolving regulatory requirements across global markets and proactively update internal stakeholders.
- Demonstrate proven experience navigating medical device or health IT regulatory submissions across at least two MEA jurisdictions (e.g., PPB Kenya, SAHPRA, NAFDAC, or Gulf authorities).
- Interpret and apply ISO 13485, ISO 14971, IEC 62304, and relevant FDA/CE/MDR frameworks to software-as-a-medical-device (SaMD) products.
- Manage regulatory submission timelines independently, coordinating across product, legal, and engineering stakeholders.
- Communicate regulatory risk and strategy clearly to both technical teams and executive leadership.
- Demonstrate familiarity with quality management systems (QMS) and post-market surveillance processes.
- Hold a Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field; a postgraduate qualification in Regulatory Affairs is a strong advantage.
- Show at least 5 years of hands-on regulatory affairs experience in the med-tech or health IT sector.
Oracle offers competitive compensation benchmarked against global technology industry standards. For a senior regulatory role of this scope based in Nairobi, the estimated monthly gross salary ranges from KES 350,000 to KES 600,000, commensurate with experience and qualifications. Oracle's benefits package typically includes comprehensive medical cover, performance bonuses, access to Oracle's employee development programs, and exposure to global projects across a Fortune 500 organization.
Ideal candidate: A regulatory affairs professional with 5+ years of experience in medical devices or health IT, a strong working knowledge of MEA regulatory bodies, and the confidence to operate autonomously within a global technology company. You are collaborative, analytically rigorous, and comfortable navigating ambiguity in a fast-moving product environment.
Do not apply if: You have no direct experience with medical device or SaMD regulatory submissions, if your background is limited to pharmaceutical (non-device) regulatory affairs without any crossover, or if you require a highly structured, slow-paced environment to perform effectively.
- Visit Oracle's official careers portal at oracle.com/careers and search for the Medical Device Regulatory Affairs Strategist position.
- Submit your updated CV along with a cover letter outlining your experience with MEA regulatory bodies and specific submissions you have managed.
- Shortlisted candidates will be contacted for an initial screening interview followed by a technical regulatory assessment.
- Note: Never pay any fee for assessments, certificates, or notarisation as part of this recruitment process.
Requirements Breakdown
Must Have
- Minimum 5 years of hands-on medical device or health IT regulatory affairs experience
- Proven track record with regulatory submissions to at least two MEA jurisdictions (PPB Kenya, SAHPRA, NAFDAC, or Gulf authorities)
- Deep expertise in ISO 13485, ISO 14971, IEC 62304, and SaMD (Software-as-a-Medical-Device) regulatory frameworks
- Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or related field
- Strong stakeholder management and ability to communicate regulatory strategy to technical and executive teams
Nice to Have
- Postgraduate qualification in Regulatory Affairs or Medical Device Compliance
- Experience with FDA, CE, or MDR frameworks
- Familiarity with quality management systems (QMS) and post-market surveillance processes
- Prior experience managing regulatory audits and compliance remediation
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Salary Context
Above-market competitive salary for a senior regulatory affairs specialist in Nairobi
The KES 350–600k/mo range reflects Oracle's multinational scale and the premium placed on regulatory expertise in MEA health tech. Senior regulatory roles in Kenya typically range KES 250–500k; Oracle's ceiling suggests investment in expertise and potential for performance-based progression. Salaries in this field are driven by experience, track record of successful submissions, and scope of regional responsibility.
About Oracle
Oracle is a global software and cloud computing giant with significant presence in enterprise health solutions across Africa and the Middle East. Their Health & Life Sciences division focuses on digital transformation in healthcare, making them a key player in driving regulatory innovation in emerging markets. Working at Oracle offers exposure to world-class product teams, established compliance infrastructure, and the chance to shape health technology standards across an entire region.
Likely Interview Questions
- 1
Walk us through a specific medical device regulatory submission you led in an MEA market. What were the key challenges, and how did you navigate them?
- 2
How do you approach translating a new product's technical specifications into a compliant regulatory dossier, and what stakeholders do you typically coordinate with?
- 3
Describe your experience managing regulatory timelines under pressure. How do you prioritize competing submissions or compliance risks?
- 4
Tell us about a time you identified a regulatory compliance gap or risk. How did you assess it, communicate it internally, and remediate it?
- 5
Which MEA health authority (PPB, SAHPRA, NAFDAC, or Gulf bodies) are you most familiar with, and what are the unique regulatory nuances you've learned?
Application Tips
Highlight specific jurisdictions and regulatory bodies you've worked with — name PPB Kenya, SAHPRA, NAFDAC, or Gulf authorities explicitly, and quantify submissions (e.g., '3 successful PPB submissions for SaMD products').
Emphasize hands-on technical expertise: include examples of ISO 13485 audits, IEC 62304 implementation, or SaMD strategy you've personally developed, not just overseen.
Demonstrate cross-functional impact: showcase instances where you've bridged product engineering and regulatory teams, resolved submission delays, or prevented compliance breaches — these directly address the role's 'critical bridge' positioning.
Career Path
Roles that lead here
Where this leads
Skills & Keywords
Honest Assessment
Green Flags
- Explicit MEA regional scope and strategic importance — this is a high-visibility role with real influence over Oracle's health product expansion in a growing market.
- Competitive, clearly stated salary range (KES 350–600k/mo) reflecting senior expertise and multinational investment in regulatory talent.
- Reputable global employer (Oracle) with established Health & Life Sciences division, suggesting structured compliance infrastructure, mentorship, and career stability.
- Strong emphasis on both technical depth (ISO standards, SaMD) and leadership (cross-functional project management, executive communication) — role rewards generalists with deep expertise.
Watch Out
- Job description is truncated mid-sentence ('at least 5 years of hands-on regulato') — clarify full experience requirement with recruiter before applying.
- Role requires mastery across 8+ diverse health authorities (SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA, PPB) with potentially conflicting standards; ensure support and resources are in place for this scope.
- No mention of relocation support, visa sponsorship, or remote work flexibility for a region-wide role — confirm logistics with Oracle before committing.
A Day in the Life
Your week typically includes 2–3 regulatory dossier reviews with product engineering teams, a submission coordination call with a health authority (PPB or SAHPRA), and a risk-assessment workshop to flag emerging compliance gaps across Oracle's health software portfolio. You spend Monday mornings updating internal stakeholders on submission timelines and regulatory changes, Tuesday afternoons reviewing labeling and clinical protocols for compliance, and midweek you lead a quality audit debrief or manage a post-market surveillance query from an authority. Much of your time is split between heads-down technical documentation work and high-level strategy conversations with executives planning Oracle's next market entry or product launch in the region.
Frequently Asked Questions
What qualifications do I need to be a Medical Device Regulatory Affairs Strategist at Oracle?
You need a Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or related field, plus at least 5 years of hands-on medical device or health IT regulatory experience. A postgraduate qualification in Regulatory Affairs is strongly preferred. You must have proven track record with submissions to at least two MEA jurisdictions (e.g., PPB Kenya, SAHPRA, NAFDAC).
Is the Medical Device Regulatory Affairs Strategist role at Oracle remote?
The job posting lists the location as Nairobi and does not explicitly mention remote work options. Contact Oracle's recruiter to confirm whether the role allows hybrid or remote flexibility, especially given its regional (MEA-wide) scope.
How much does a Medical Device Regulatory Affairs Strategist earn at Oracle in Nairobi?
Oracle offers a competitive salary range of KES 350,000–600,000 per month for this role, reflecting the senior level of expertise required and Oracle's multinational scale. The exact salary within that range typically depends on experience, track record of successful submissions, and negotiation.
What are the career growth opportunities for this role?
This role can lead to senior positions such as Head of Regulatory Affairs for a regional or global health division, or Regulatory & Compliance Director for enterprise health software. The exposure to Oracle's product strategy and MEA regulatory landscape positions you for both specialist and leadership paths in health tech compliance.
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