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Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

We don’t just build technology. We build hope for everyone dealing with Cancer.

The Lead Regulatory Affairs (RA) is the organization’s senior-most technical regulatory expert, accountable for shaping, influencing and executing the regulatory strategy for BL Linac and contribute to strategies across product lines.

The role operates in high ambiguity, and makes strategic decisions involving technical debt, regulatory constraints, cost/value and strategic priorities. The Lead RA Engineer contribution has impact over scale of years, not just over current release cycles. The role requires skills to influence across teams and functions, and to make risk-based calls where guidance is evolving or incomplete.

The Lead RA role provides Business Line-level regulatory leadership, anticipating global regulatory requirements and ensuring compliance.   The role influences and drives regulatory decisions on product architecture, compliance and risk management, and lifecycle decisions to ensure successful and sustainable regulatory outcomes.

The Lead RA acts as a strategic partner to R&D, Quality, Clinical, Cybersecurity, and Product Management and represents the company in key interactions with regulatory authorities, Notified Bodies, and external stakeholders.

What you’ll do at Elekta:

Your responsibilities will include but are not limited to:

Regulatory Strategy & Pathfinding

• Develop and lead regulatory strategies for new and complex technologies, including connected systems, AI/ML features, and cybersecurity‑critical features.
• Define global regulatory pathways and approval strategies (FDA, EU MDR/IVDR, UKCA, Health Canada, PMDA, etc.) for Linac products and contribute to RA strategy planning across product lines.
• Oversee preparation, review and approval of complex regulatory submissions including: (FDA, EU MDR/IVDR, UKCA, Health Canada, PMDA, etc.)
• Anticipate regulatory trends and translate them into actionable guidance for internal teams (e.g., EU AI Act implications, FDA evolving AI/ML expectations).

Technical Influence

• Collaborate with engineering leaders to ensure design decisions optimize regulatory pathways and long-term compliance.
• Assess innovations for regulatory impact early in concept phases and drive clarity where guidance is immature or ambiguous
• Maintain deep expertise in worldwide standards and regulatory requirements for radiation therapy, oncology devices, imaging systems, and software‑driven medical devices.

Submission Leadership & Documentation Oversight

• Lead or direct complex submissions such as FDA 510(k), De Novo, EU MDR
• Ensure integration of hardware, firmware, and software evidence into cohesive regulatory packages.

Risk Management & Compliance Frameworks

• Guide teams to accomplish compliance with IEC 60601, IEC 62304, IEC 81001‑5‑1, and other relevant standards.

• Provide senior oversight for standards interpretation.

• Lead regulatory readiness activities for FDA inspections, EU MDR Notified Body audits, PMDA / NMPA reviews, and supplier audits.

External Authority Engagement

• Lead interactions with FDA, Notified Bodies, and global regulatory agencies, including: Pre-submissions, Panel meetings, Technical file reviews, Standards interpretation discussions

• Advocate for the company’s regulatory positions and technology decisions at senior levels.

Cross-Functional Leadership & Mentorship

• Partner closely with R&D, Engineering, Product Management, Manufacturing, Supply Chain, Quality, and Order Fulfilment to ensure regulatory requirements are embedded early in design and development.

• Act as technical mentor to RA staff and cross-functional teams.

• Build regulatory capability across R&D, quality, and product teams.

• Drive cross-functional regulatory decision making, ensuring alignment with Elekta’s QMS and business priorities.

Lifecycle Management & Change Leadership

• Lead regulatory assessments for complex design changes (hardware revisions, software & firmware updates, cybersecurity patches)
• Drive continuous improvement of regulatory systems and processes.

The right stuff:

• Ability to lead without formal authority across departments and geographies.
• Executive-level communication skills, capable of translating regulatory complexity into business language.
• Proven ability to influence senior engineering and product leaders.
• Skilled at managing ambiguity and making high-judgment, risk-based decisions.
• Experience mentoring and upskilling RA professionals.
• Experience and ability to work within a multi-cultural environment.
• Excellent skills in English, both verbally and in writing.

What you bring:

*We encourage you to apply even if you don’t meet every requirement—your unique skills and experiences might be exactly what we're looking for!  

• Deep expertise in global medical device regulations (FDA QSR, QMSR, EU MDR, ISO 13485).
• Strong knowledge of safety standards such as IEC 60601, IEC 60601-1-2, IEC 62366, and other standards as applicable.
• Advanced understanding of software and firmware lifecycle standards: IEC 62304, IEC 81001 5 1.
• Proficiency in risk management (ISO 14971) and cybersecurity regulatory expectations (FDA cybersecurity, IMDRF, MDCG).
• More than 7 years in regulatory affairs, with experience in high-complexity devices.
• Demonstrated history of successful submissions for hardware/software-integrated devices.
• Experience as primary RA lead in interactions with FDA or Notified Bodies.

What you’ll get:

In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.

• Work Pattern (you are required to work from the Crawley HQ 4 days a week with 1 day WFH)
• Up to 25 paid vacation days (plus bank holidays)
• Holiday Purchase Scheme
• Private Medical Insurance
• Attractive Employer Pension Contribution Package
• Cycle to work scheme
• Life Assurance
• Onsite subsidized restaurant, offering budget-friendly dining
• Love electric (Electric vehicle salary sacrifice scheme)

Hiring process
We are looking forward to hearing from you! Apply by submitting your application and résumé in English, via the “Apply” button. Please note that we do not accept applications by e-mail.

Your Elekta contact
For questions, please contact the Talent Acquisition Partner responsible, Sarah Elmasry, at [email protected]. We do not accept applications through e-mail.

We are an equal opportunity employer

We are an equal opportunity employer. We evaluate qualified applicants without regard to age, race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.