Senior Director leading innovative global regulatory strategies for oncology products at Lilly. Engaging with regulatory teams and fostering communication for effective product development.
About the role
- Regulatory Specialist ensuring compliance across FDA and international regulatory frameworks for SaMD products. Collaborating on quality management and supporting product development for global markets.
Responsibilities
- Prepare and manage FDA submissions including 510(k), DeNovo, Pre-Submission, and Breakthrough Designation
- Ensure completeness and compliance of all regulatory documentation
- Coordinate cross-functional inputs for submissions (clinical, risk, usability, technical documentation)
- Support development of US reimbursement strategy (CPT codes, payer engagement)
- Ensure compliance with FDA, SOC2, and future MDSAP requirements
- Support SOC2 certification processes and data privacy/security compliance
- Support MDR compliance and technical documentation
- Ensure alignment with ISO 13485 and ISO 14971 requirements
- Contribute to global regulatory strategy and future certifications (e.g. MDSAP Canada)
- Maintain and improve QMS processes related to regulatory compliance
- Review promotional and training materials for regulatory compliance
- Support design control, risk management, and documentation updates
- Support internal, external, and notified body audits
- Perform risk assessments and usability evaluations
- Support supplier/distributor evaluation and compliance processes
- Work with clinical teams on retrospective and prospective studies
- Collaborate with R&D, product, and legal teams on regulatory requirements
- Support regulatory input in product development and change management
- Improve regulatory and quality processes
- Support integration of compliance into development lifecycle
- Monitor regulatory landscape (FDA, MDR, global)
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field
- 7+ years of experience in regulatory affairs (FDA focus)
- Experience with:
- FDA submissions (510(k), DeNovo, Pre-Sub)
- SaMD (Software as a Medical Device)
- ISO 13485 and ISO 14971
- MDR and EU regulatory framework
- Knowledge of clinical studies (retrospective & prospective)
- Understanding of US reimbursement landscape is a plus
- Experience with SOC2 / MDSAP is a plus
- Strong analytical and problem-solving abilities
- High attention to detail
- Ability to manage multiple projects simultaneously
- Strong communication and stakeholder management skills
- Ability to work cross-functionally in an international environment
- Excellent verbal and written English communication skills
Benefits
- A chance to be part of an exceptional team driving innovation in healthcare.
- A competitive salary in a supportive work environment that fosters work-life balance.
- Opportunities for professional growth and development in an international setting.
- A culture of collaboration and inclusion, which is fundamental to our ethos.
- Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture.
Job title
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