Regulatory Affairs Specialist

BD; Limerick; On-site; EUR 57,000 - 86,000; Full time

Job summary

BD in Limerick, Ireland is hiring a Regulatory Affairs Specialist to drive regulatory activities for new and existing medical device products. You will collaborate with R&D, Quality and Engineering to ensure CE marking from concept to commercialization, and manage regulatory dossiers for international submissions.

The role requires MDR/MDD experience, a science/engineering degree, and ability to work on site in Limerick four days per week.

Qualifications

• Proven regulatory affairs experience within the medical technology industry or equivalent.
• Prior working experience on MDR preferred.
• Minimum of a Bachelor’s degree in scientific or engineering discipline.
• Demonstrated compliance experience with Class IIa/IIb - MDD/MDR medical devices, including (P)EMS.

Responsibilities

• Lead RA activities on New Product Development projects to support CE marking from concept to commercialization.
• Lead sustaining engineering projects for changes to released products.
• Develop regulatory strategies for product release and product change assessments.
• Ensure compliance to MDR/MDD and internal quality systems in technical documentation.
• Prepare regulatory dossiers for submission to Health Authorities (OUS).
• Attend audits to represent RA positions and processes.

Skills

International Standards

Medical Devices

Education

Bachelor's degree in science/engineering

Job description

We are the people who give possibilities purpose

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.

Job Description

BD are hiring a Regulatory Affairs Specialist to join the BD team in Limerick, Ireland. This is an exiciting opportunity to play a key role in supporting both new and existing medical device products, partnering closely with R&D, Quality, Engineering and other cross functional teams.

The Regulatory Affairs function at BD combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards.

The Regulatory Affairs Specialist must gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations, also identifying, preparing and collecting data needed to obtain and maintain certifications and commercialization authorizations of BD products.

You will have in-depth experience, knowledge, and skills in own job family. Applies knowledge and skills to a wide range of standard and non-standard situations. Works independently with minimal guidance. Acts as a resource for colleagues with less experience

Positions in the professional & technical career track contain jobs that require the consistent application of knowledge in a specialized area. Typically, a university degree is required. Serves as a professional individual contributor / technical expert career ladder.

Job Responsibilities

• Works with R&D to lead RA activities (as RA lead) on New Product Development projects to support the product development and CE marking from concept to commercialization.
• Supports as RA lead on sustaining engineering projects for changes to released products.
• Propose workable solutions for resolution of complex regulatory challenges, hands-on approach in driving projects to completion.
• Maintain high level of quality and compliance (to MDR/ MDD/ company quality systems) in technical document preparation and review & approval of various product/ project specific documentation.
• Participate to the review of process/product changes, labeling, claims, product complaints, APs (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to international requirements.
• Active inputs into development and review of quality system procedures & work instructions, CERs/ PSURs and input into risk mgmt.
• Development of regulatory strategies for product release and product change assessments.
• Works with BD processes and cross functional teams to assess changes in standards/ regulations and help determine their impact to Business.
• May support transition of products from MDD tech files to MDR technical documentation and any other business critical projects, as needed.
• May prepare regulatory dossiers for submission to Health Authorities in support of international product registrations OUS (outside US).
• May Attend to audits performed by internal and external authorities to represent RA positions and processes.

Skills and Experience Required

To be successful in this role you will have proven regulatory affairs experience within the medical technology industry or equivalent.

Prior working experience on MDR preferred.

Minimum of a Bachelor’s degree in scientific or engineering discipline

You should have demonstrated compliance experience with Class IIa/IIb - MDD/MDR medical devices, including (P)EMS - (Programmable) Electrical Medical Systems

Knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking

• Experience working with International Standards like IEC/EN 60601-1 (safety)/ 60601-1-2 (EMC)/ 62304(software)/ 62366(usability), ISO 14971 (Risk Management) and ISO 13485 (QMS). Good working knowledge of Design Control, Software Life Cycle, Risk Mgmt, V&V processes

You should be an enthusiastic team player, agile in execution with sense of ownership, in a complex and fast evolving environment.

Please note: This role is based at our Limerick site where you will be required to be on site 4 days per week.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

• International Standards, Medical Devices

Optional Skills

.

Primary Work Location

IRL Limerick - Castletroy

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Salary Range Information

€56,600.00 - €86,300.00 EUR Annual