Das ist der Job
Are fluent in English; proficiency in additional languages is an asset. #J-18808-Ljbffr
Darum lohnt es sich
You will serve as the Device Regulatory Lead within a cross-functional regulatory strategy team, working in close partnership with CMC, device engineering, and quality colleagues to ensure compliant, timely, and scientifically credible submissions to health authorities worldwide.
Have 10 or more years of regulatory affairs experience, with proven and recent expertise in drug-device combination product submissions and/or medical devices for US, EU, and international markets.
Have a demonstrated ability to develop global regulatory strategies and assemble dossiers for submissions including EU MAA, NBOp, CTA, US IND, NDA, BLA for combination products, 510(k), and PMA; international experience is strongly preferred.
Possess a solid understanding of the drug-device combination and medical device regulatory framework across EU, US, and international markets, including ICH, EU-MDR, MDSAP, ISO 13485, cGMP for combination products, QMS, technical file requirements, eCTD, and MCDG guidelines.
Are a strong team player who thrives in a highly multidisciplinary environment and communicate effectively with colleagues and stakeholders from diverse professional backgrounds.
Your Role In this pivotal role, you will own and drive the global regulatory strategy for drug-device combination products, shaping the pathway from early development through to approval and lifecycle management.
Your ability to build trusted relationships with regulatory agencies and to translate complex regulatory requirements into clear, actionable strategies will be central to accelerating the development of innovative combination products.
Operating with considerable autonomy, you will influence both internal decision-making and external regulatory outcomes, contributing to a culture of regulatory excellence and risk-based thinking across the R&D organization.
Who You Are Hold a degree in a life science or related discipline (MSc minimum or equivalent); a higher degree such as a PhD in a scientific discipline is preferred.
Have a proven track record of productive collaboration with regulatory authorities through scientific advice meetings, and act as a credible, influential spokesperson during such interactions. Prior experience with regulatory CMC and connected drug-device combination products for medicinal products is an advantage.
