The Associate Director / Senior Manager, Device Regulatory role offers the opportunity to play a pivotal role in advancing innovative medical device programmes through global regulatory strategy, submissions, and compliance activities. This position is ideal for an experienced regulatory professional who thrives in a cross-functional environment and is passionate about supporting the development, approval, and commercialisation of cutting-edge healthcare technologies across major international markets.
Responsibilities
Develop and implement regulatory strategies for medical device products, supporting new product development, approvals, and lifecycle management while aligning with business objectives and regulatory requirements, including U.S. FDA and CE marking regulations.
Lead and oversee regulatory submissions, including 510(k), PMA, IDE, and De Novo applications, managing activities from pre-submission interactions through to regulatory approvals.
Ensure compliance with applicable regulatory requirements and quality standards, including 21 CFR Part 820 (QSR), ISO 13485, CE marking requirements, and other relevant regulations.
Conduct regulatory intelligence activities and risk assessments, monitoring evolving regulatory requirements and evaluating their impact on existing and future programmes.
Provide regulatory guidance and training to cross-functional teams including R&D, Clinical, Marketing, and Quality functions to ensure regulatory considerations are incorporated into development and commercialisation plans.
Collaborate with Global Regulatory Affairs in interactions with regulatory authorities, managing agency communications, responses to enquiries, and ongoing regulatory obligations.
Work closely with Global Regulatory Affairs and technical teams to establish best practices and maintain excellence in regulatory processes and documentation.
Requirements
Education
Bachelor’s degree in Life Sciences, Engineering, or a related field.
Advanced degree (Master’s, PhD, or JD) in Biomedical Engineering or a relevant scientific discipline preferred.
Skills and Expertise
In-depth knowledge of medical device regulations and requirements, including U.S. FDA regulations.
Strong expertise in 21 CFR Part 820 (QSR), ISO 13485, FDA guidance documents, and medical device regulatory frameworks.
Excellent technical writing and documentation skills with the ability to prepare high-quality regulatory submissions.
Strong analytical and strategic thinking skills, with the ability to assess regulatory risks and develop effective regulatory strategies.
Proven project management capabilities with the ability to manage multiple priorities and regulatory deadlines.
Strong leadership, interpersonal, and communication skills, including the ability to collaborate effectively with cross-functional teams and regulatory authorities.
Regulatory Affairs Certification (RAC) or equivalent certification is advantageous.
Preferred Skills
Familiarity with global regulatory frameworks, including EU MDR, MDSAP, and other international requirements.
Knowledge of emerging regulatory trends and digital health regulations, including software and AI-based medical devices.
Experience with Investigational Device Exemptions (IDEs).
Experience
Minimum 10 years of experience in Regulatory Affairs, including at least 5 years within the medical device industry.
Strong experience with regulatory requirements in major jurisdictions, including U.S. FDA and CE marking frameworks.
Demonstrated success in regulatory submissions and product approvals, including 510(k), PMA, or equivalent pathways.
Experience with Class III medical devices or higher preferred.
Experience with combination products and/or Software as a Medical Device (SaMD) is advantageous.
Proven experience managing cross-functional projects.
Benefits
Welfare and insurance coverage provided.
About the Company
A global biotechnology company focused on developing innovative investigational therapies and technologies for the treatment of cancer. The organisation is dedicated to advancing novel therapeutic platforms and developing both drug and medical device solutions with the goal of improving outcomes and quality of life for patients worldwide.