BD (Becton, Dickinson and Company) Regulatory Affairs Leader - International Infusion in Eysins, Switzerland
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
About Regulatory Affairs at BD
Regulatory Affairs helps to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric approach.
About the role
The role supports the successful implementation of regulatory strategies and key initiatives on product and process compliance improvement. You coordinate resources to deliver statutory activities in EU and International markets for the International Infusion Platform. This includes Infusion Pumps, software, accessories and disposable infusion sets.
Driving the regulatory process for products launch in new markets and maintaining existing registrations aligned with the business strategic plan
Facilitating the preparation of the documentation to acquire, maintain, or renew International Registrations along the product lifecycle
Supporting the resolution of roadblocks and the communication of major issues
Using BD's Regulatory Intelligence resources to identify new or changing regulations and standards. Update Leadership Teams on Regulatory requirements' evolution.
Leading and contributing to projects (Quality Improvement, EU MDR, Mergers & Acquisitions, etc.):
identifying and communicating applicable Regulatory requirements and strategies to acquire needed clearances and approvals
minimizing time to product launch without compromising compliance
Reviewing submissions and assess major process/product changes to ensure compliance
Representing RA in the deployment of initiatives (systems, policies and procedures)
Provide regulatory support to post-market surveillance and Regulatory Compliance activities. This includes reviewing/approving customer communications, product labelling, advertising & promotional
We are looking for candidates with a relevant degree (Electronics, Biomedical or Mechanics Engineering, Biology, Chemical or another relevant subject area), or equivalent experience in the field of Programmable Electrical Medical Systems. You combine knowledge of scientific, regulatory, and a keen eye for business. You ensure that products are developed, manufactured, distributed, and placed on the markets compliantly.
We require a proven track record in managing teams directly or indirectly. Leadership and project management skills are needed to prioritize while handling several projects and delegate to teammates according to business needs. Driven by your continuous improvement mentality, you detect, propose and support the implementation of significant opportunities in compliance, cost, cycle time, process, quality, etc.
Strong record of successful product submission and registrations of medical devices. Excellent technical writing skills to prepare regulatory documentation and connect with Authorities
Full ownership of the regulatory domestic framework (EU MDD/MDR), main international schemes (US/FDA, ANZ & TGA, Canadian HC, CFDA, MDSAP, …) and technical standards (ISO 13485, IEC 60601 series, etc.).
Solid understanding of ISO 14971 Risk Management, Software Life Cycle, functional Usability/Human factors, Clinical Evaluation, Reliability and PMS/Vigilance processes. Basic ISO 10993 biocompatibility, stability and sterilization aspects is a plus
Proficiency in English
Click on apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work Location
CHE Eysins - Business Park Terre-Bonne
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.