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.

As a Regulatory Affairs Specialist, you will be a key stakeholder in this new central activity by creating tools, centralizing data, training customer facing teams, responding to customers, filling performance indicators, maintaining. You will be part of the MDR/IVDR flex RA supporting team, executing RA action items as per the strategy. You will be a key partner for local country RA, providing them with adequate support in dealing with MDR/IVDR matters and BU RA EMEA. Thanks to the centralized data and tools created, you will be able to support local in country notifications, tenders and import activities as needed in your region.

You will also collate available documents and build MDR/IVDR transition package for products to support the subsequent notifications/registrations. You will work closely with supply chain, BU EMEA RA and LM to anticipate challenges and participate in mitigation plans.

Other Key Responsibilities:-

• Working on registration/notifications files (products & sites) submissions to support the local RA teams where needed
• Product registration maintenance
• Supports all registration requests by coordinating the administrative part through applicable channels
• Develops and maintains an adequate documentation and communication system
• Research and analyze regulatory information and determine acceptability of data, procedures and other product related documentation presented in support of product registration.
• Develop and maintain current regulatory Knowledge and keeps tabs on regulatory procedures and changes in a diverse region.
• Ensure all products meet regulatory requirements by supporting all assigned regulatory aspects of products approval and post market compliance
• Prepare the submission/notification files depending on the different local requirements communicated by the local teams, with a capability of multitasking, where needed.
• Assist the RA Manager/ supervisor in defining Regulatory processes consistent with business strategies
• Prioritizes projects and plans submissions across the region based on aligned priorities with the corresponding partners
• Maintains the prioritization tool and internal databases, such as Requirement Trackers, Regulatory tracker per region and business and develops an efficient record keeping tool

About You:-

• Minimum 1-2 years of Regulatory Experience is required, preferably in Medical Devices, Pharmaceutical or any similar industry.
• Bachelor’s degree, preferably in Sciences, Engineering, or equivalent
• Good communication skills
• Be able to work in a very diverse Regulatory environment, with different requirements and regulations.
• Must be detail oriented
• Project organizational and prioritization skills
• Flexibility to multitask and shuffle between projects based on emerging priorities
• Fluent in spoken and written English

Why join us?

A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you 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.