Senior Regulatory Affairs Specialist

1 day ago

Winnersh, United Kingdom BD Full time

**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 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Excellent opportunity to experience an International Regulatory Affairs role within a leading medical devices Corporation, to build upon your professional knowledge of global market clearance procedures as well as of active (electro-medical) standards compliance.

**Reports to: Senior Manager Regulatory Affairs - International Infusion**:
**Competitive Salary, Bonus, Hybrid working and excellent benefits**:
**About the role**:
The function of Sr. Regulatory Affairs Specialist is to combine knowledge of scientific, regulatory and business issues to enable product development, manufacture and life cycle maintenance to meet applicable regulatory requirements and applicable technical standards.

The individual has to gain department and platform level influence by participating to all RA activities and sharing regulatory expertise to demonstrate compliance with changing global regulations, also identifying, preparing and collecting data needed to obtain and maintain certifications and commercialization authorizations of BD products.

You should be an enthusiastic teammate, able to participate with ownership in a complex and fast evolving environment. Strong knowledge in international standards and regulations including IEC 60601-1, IEC62304, IEC 62366 preferred. Experience with CE Marking under MDD/ MDR required.

**Main responsibilities will include**:

- Lead RA representative for design change assessment projects for active medical devices (PEMS), responsible for assessing regulatory impact of the change - determining testing needs/ documentation needs/ registration needs. Close liaison with supply chain/ regional regulatory folks etc. to ultimately implement the change in production.
- Lead and execute international product registrations attending to individual country specific requirements; monitor and report progress
- Participate to the review of process/product changes, labelling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements;
- Prepare and maintain regulatory files such as STED and MDD/MDR Technical Files;
- May participate in cross-functional product development teams as the regulatory representative; development of regulatory strategies
- May attend to audits performed by internal and external authorities to represent RA positions and processes;
- Assesses changes in regulations and helps to determine their impact;
- Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.
- Handle CAPAs to implement corrective and preventive actions
- Drive regulatory affairs procedural updates, as needed, in collaboration with cross functional inputs.

**About you**:

- Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD/MDR CE Marking;
- Good working knowledge of Design Control, Software Life Cycle, Risk Management, V&V processes;
- Solid knowledge and material experience in international registrations/approval process for medical devices
- Degree or equivalent in engineering or scientific discipline, or equivalent proven experience.

**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.

**Primary Work Location**: GBR Winnersh - Eskdale Road

**Additional Locations**:
**Work Shift**:

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