Senior Manager, Regional Regulatory Affairs

Job title:

Senior Manager, Regional Regulatory Affairs

Company

Novocure

Job description

Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications – non-small cell lung cancer, pancreatic cancer and other types of solid cancers.To support our team in Baar, Switzerland we are looking for aSenior Manager, Regional Regulatory AffairsWe are seeking a seasoned and strategic Senior Manager, Regulatory Affairs Regions to lead regional regulatory strategy and execution for our Class III medical devices across assigned geographies (Germany, France an additional European markets). This role focuses on regulatory approvals, lifecycle management, and ensuring regional compliance with local health authority requirements.Your responsibilities:

• Serve as the regulatory lead on cross-functional project teams for new product development, sustaining engineering, and global market expansion for Class III devices.
• Review and maintenance of high-quality regulatory dossiers, including PMAs, IDEs, technical files, and European submissions (e.g., EU MDR).
• Act as the primary liaison with regulatory authorities (e.g. Notified Bodies), managing meetings, audits, and inquiries.
• Provide regulatory input during design and development phases, ensuring compliance with applicable global regulations and standards (21 CFR 814, 820, ISO 13485, EU MDR).
• Review and approve product labeling, IFUs, and promotional materials for regulatory compliance specific to the region.
• Stay current with evolving regulatory landscapes and provide strategic recommendations to ensure timely approvals and risk mitigation.
• Collaborate with Quality, Clinical, R&D, and Marketing teams to align regulatory strategy with business goals.
• Serve as a mentor or technical resource to junior team members, without direct line management responsibilities.

Your profile:Qualifications:

• Bachelor’s degree in a life science, engineering, or regulatory discipline.
• Minimum 5 years of regulatory affairs experience in the Class III medical device industry.
• Demonstrated success leading PMA submissions.
• Deep understanding of EU MDR, and international medical device regulations.
• Strong writing, problem-solving, and project management skills.

Knowledge:

• Advanced degree (MS, PhD, or JD).
• RAC certification.
• Experience with combination products or active implantable devices (AIMDs).

We are looking forward to receive your application Natalia Munchow, Senior Talent Acquisition Partner through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.

Expected salary

Location

Baar, Zoug

Job date

Thu, 21 Aug 2025 04:53:13 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsineu.net) you saw this job posting.