Service Quality Specialist

4 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 healthTM 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 mentorship 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 product placement in Europe and other regulatory jurisdictions that apply to new product introduction, major design changes; 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 development environment by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
  • Responsible for delivery and reporting on function KPIs
  • May act as liaison with notified bodies, and international regulators regarding product submissions and audits.
  • Collaborate with internal and external customers including 3rd party manufacturers in defining regulatory compliance strategies for commercialisation.
  • Lead and implement premarket applications and proposed device modifications for CE Marking for EU and other international regulations with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.) Prepare robust non-filing justifications for changes that do not require a CE submission.
  • RA accountability in CT representation - inputs for product development through RA lens, review and collaborate on design and development documents, as applicable.
  • Provide regulations and standards interpretation expertise. Dialogue with test house for test reports issue and any technical interpretation escalations as appropriate
  • Build 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.
  • Proactively lead regulatory efforts required to comply with new regulations and requirements, i.e., EU MDR, MDSAP.
  • Develop or provide input to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
  • Keep abreast on standards, guidances, and regulations affecting BD; assess and communicate potential impact.
  • Identify ways to improve the efficiency of current work process and implement 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 standardisation 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 Development

Primary Work Location

GBR Winnersh - Eskdale Road

Additional Locations

Work Shift

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