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