Regulatory Affairs Manager

2 weeks ago

Winnersh, United Kingdom BD (Becton, Dickinson and Company) Full time

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health? is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why join us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us

About the role

This role will be working in BD-Medication Management Solutions (MMS) on Regulatory Affairs projects that will span the International Infusion Solutions portfolios. This position will hold line management responsibilities.

This is a highly visible role within the organization, and you will participate in multi-functional teams as the regulatory expert. The role will provide guidance to project teams as well as other RA teams, develop and implement processes and systems, and stay abreast of global regulations to help MMS achieve its business goals within the scope of this position. This role will develop regulatory affairs strategy for continued product placement in Europe and other regulatory jurisdictions focusing on product modifications and continued compliance to the latest regulations; exhibit strong cross functional influencing skills, lead initiatives and ensure direct reports are well supported and empowered.

Main responsibilities will include:

  • Represent RA and demonstrate leadership in complex product life cycle management environment by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout product lifetime.
  • Responsible for delivery and reporting on function KPIs
  • May act as liaison with notified bodies and other international regulators pertaining to product submissions and quality & regulatory audits. Manage product and process change notifications to Notified Body - engage in discussions as needed for successful submissions.
  • Lead and execute initiatives associated with life-cycle management such as - proposed device modifications for CE Marking and other international regulations; review CER/ CEP/ PSUR/ PMCF.
  • End of Life management from a regulatory perspective
  • Oversee International registrations activities including renewals and change notifications to countries. Prepare robust non-filing justifications for changes that do not require a CE significant change notification.
  • Proactively lead regulatory efforts required to comply BD products with new regulations and requirements such as EU MDR, MDSAP, UKCA etc. Including liaison with 3rd party manufacturers for regulatory compliance to the latest regulations.
  • Review and approve product labelling, promotional, and advertising materials to ensure regulatory compliance and adhering to BD Ad-Prom policies.
  • Create and maintain product technical and STED files in accordance with MDR, MDD, UKCA as applicable.
  • Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.
  • Develop or provide input to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
  • Identify ways to improve the efficiency of current work process and execute them.
  • Performs other duties and assignments as required.

About you

Professional Skills & Key Competencies

  • Analyse, and interpret scientific, technical, and regulatory literature and documents. Clarity in understanding and execution
  • Excellent interpersonal, communication and partnership traits
  • Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure and/or where only limited standardization exists.
  • Strong influencing and negotiation skills.
  • Work with a global perspective, customer focus, strong cross-functional collaboration and teamwork skills.

Qualifications and Experience

  • Bachelor's degree required (Master's degree in life sciences field preferred)
  • Minimum 5 years of strong Regulatory Affairs experience in the medical device industry.
  • Working knowledge of electro-medical device including stand-alone software, device interoperability and IEC and 62304 and 62366 standards.
  • Sound understanding of design control processes.

Click on apply if this sounds like you

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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, military eligibility or veteran status, or any other protected status.

To learn more about BD visit:

Regulatory Affairs Manager - Product Life Cycle Management

Primary Work Location

GBR Winnersh - Eskdale Road

Additional Locations

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