Our vision for Medication Delivery Solutions at BD

As a leading manufacturer and supplier of products that are used daily in healthcare, the Medication Delivery Solutions (MDS) team provide a wide range of products for injection and infusion therapy, regional anaesthesia and closed medication management.

About the role

The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform, part of the Medication Delivery Solutions business unit of Becton Dickinson (BD). This is a highly visible role within the organisation that will participate in multi-functional teams as the regulatory expert on compliance projects, product engineering, new product development, and other regulatory-related development initiatives and maintenance activities. The role will work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are identified and effectively addressed within projects.

Main responsibilities will include:

• Serve as the Regulatory Affairs representative on cross-functional product development teams, ensuring compliance with U.S., EU MDR, and global regulatory requirements for new products and design changes

• Lead preparation, submission, and lifecycle management of regulatory filings, including FDA 510(k), Pre/Q-Sub, and EU technical documentation for CE marking

• Act as primary liaison with FDA, EU Notified Bodies, and other regulatory authorities during submissions, audits, and ongoing compliance activities

• Serves as a point of contact for EU notified bodies, and other regulatory agencies during submissions and surveillance audits.

• Independently assess product and process changes for regulatory impact and determines appropriate submission or non-submission pathways

• Develop and execute global regulatory strategies to support timely market access and lifecycle management of medical devices

• Review and approve design control documentation, labeling, promotional materials, and other regulated content to ensure compliance with applicable requirements

• Identify, evaluate, and communicate regulatory risks, and recommend mitigation strategies to cross-functional stakeholders

• Maintain current knowledge of evolving global regulations and proactively advise project teams on potential impacts

• Collaborate with global regulatory partners to support international registrations and market expansion

• Drive continuous improvement by identifying process inefficiencies and implementing enhancements to regulatory workflows

• Executes the above tasks with limited supervision

About you

• Bachelor’s degree in Regulatory Science, Biomedical, Pharmaceutical, or related scientific field (or equivalent)

• 5–7 years of Regulatory Affairs experience in the medical device industry, preferably with Class II and/or Class III devices

• Demonstrated experience preparing and managing regulatory submissions (e.g., 510(k), EU MDR technical documentation)

• Strong working knowledge of U.S. FDA regulations, EU MDR (Regulation (EU) 2017/745), and applicable global regulatory frameworks

• Experience operating within an ISO 13485 quality system and design control environment

• Proven ability to manage multiple projects independently in a dynamic, matrixed organisation

• Strong analytical, critical thinking, and decision-making skills, with the ability to translate regulatory requirements into actionable strategies

• Effective communication and collaboration skills, with experience working across cross-functional and global team

Additional Qualifications

• Demonstrated ability to mentor or guide colleagues and influence stakeholders

• Strong attention to detail with a proactive, solution-oriented mindset

• Experience in regulatory strategy development and risk-based decision-making

• Continuous improvement mindset with ability to identify and implement process enhancements

• Proficiency with standard business tools (e.g., Microsoft Office suite)

• Ability to operate effectively in a global, multicultural environment and travel as needed

Salary €85K - €95K + Bonus + Benefits

Click on apply if this sounds like you!