обновлено 5 дней назад
Principal Scientist, CMC Regulatory Affairs - Combination Products (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Scientist, CMC Regulatory Affairs - Combination Products (Medical Devices): Developing and executing global regulatory strategies for drug-device combination products, submissions, Health Authority interactions, and lifecycle management with an accent on CMC expertise, device requirements, and regulatory risk assessment. Focus on interpreting evolving global regulations, reviewing device-specific submission content, assessing manufacturing and product changes, and addressing complex regulatory issues across cross-functional teams.
Location: Hybrid role based in Allschwil, Switzerland. The position requires 10% domestic or international travel.
Company
Johnson & Johnson MedTech develops healthcare solutions and innovative medicines focused on preventing, treating, and curing complex diseases.
What you will do
- Provide CMC regulatory subject matter expertise for drug-device combination products and related medical device constituent parts.
- Develop and execute regulatory strategies for clinical, marketing, and lifecycle management submissions.
- Prepare for and support Health Authority and Notified Body interactions, including briefing books and responses.
- Review combination product and device-specific submission content, technical dossiers, and applicable design control deliverables.
- Assess regulatory impacts of manufacturing, device, and product changes across global markets.
- Monitor emerging regulations and contribute to regulatory process improvements, training, and cross-functional capability development.
Requirements
- Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline.
- At least 8 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development, including post-graduate education.
- Experience in pharmaceuticals, biotechnology, medical devices, combination products, or another regulated healthcare environment.
- Knowledge of scientific, technical, regulatory, or product development principles for regulated healthcare products.
- Ability to develop regulatory strategies, collaborate cross-functionally, influence decisions, and communicate effectively in writing and verbally.
- Strong analytical problem-solving, attention to detail, and organizational skills.
Nice to have
- Advanced degree such as a Master’s, PharmD, or Ph.D. in a relevant discipline.
- Experience with combination product development, design controls, risk management, human factors, usability engineering, and quality management systems.
- Experience with global submissions, Health Authority and Notified Body interactions, and device-related CMC content.
- Knowledge of FDA combination product regulations, 21 CFR Part 4, QMSR, EU MDR, and related global guidance.
- Regulatory Affairs Certification (RAC).
Culture & Benefits
- Work in a global, matrixed healthcare organization.
- Collaborate with regulatory, scientific, technical, and cross-functional experts.
- Contribute to products spanning synthetic and biologic medicines and multiple therapeutic areas.
- Participate in initiatives focused on regulatory compliance, process improvement, training, and organizational capability building.
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