Über diese Regulatory Affairs Manager Stelle bei BD
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
The Regulatory Affairs manager serves as a key regulatory contact for Authorised Representative activities and supports the effective implementation and maintenance of regulatory compliance processes related to those activities.
The Regulatory Affairs Manager will provide regulatory expertise and oversight to ensure that the activities within the EU RA team meet the regulatory requirements of EU, UK, and Swiss Authorised Representatives.
This is an exciting opportunity to work at the centre of regulatory strategy, compliance, and stakeholder engagement in a highly regulated and fast-evolving industry.
Job responsibilities:
- Ensure compliance with applicable EU, UK, and Swiss regulations by fulfilling the responsibilities of the Waters Authorised Representative and supporting related Economic Operator obligations.
- Review and approve Authorised Representative mandates, agreements, and regulatory documentation, and act as a regulatory signatory where required.
- Develop, maintain, and improve procedures, work instructions, and quality system processes supporting Authorised Representative activities and regulatory compliance.
- Provide regulatory guidance on Authorised Representative, importer, distributor, and other Economic Operator requirements to internal and external stakeholders.
- Support regulatory inspections, audits, and interactions with Competent Authorities, Notified Bodies, customers, and other stakeholders, including the timely management of regulatory inquiries and escalations.
- Monitor regulatory developments, assess business impact, and support implementation of regulatory and organizational changes while driving continuous improvement of Economic Operator processes.
- May perform other duties as required in support of the EMEA RA department.
Education and Experience:
- Educated to a minimum of Batchelor’s or Master’s degree level, preferably in a scientific, engineering, regulatory or related discipline.
- A minimum of 5 years relevant experience working within quality or regulatory affairs department in the medical devices or in vitro diagnostic medical device industry.
- Experience with EU MDR, IVDR, MedDo, IvDO, MHRA and Economic Operator requirements is preferred.
- Experience supporting regulatory inspections, audits, or Competent Authority interactions is desirable
Knowledge and Skills:
- Strong Knowledge of medical devices or in vitro diagnostic medical devices regulations in Europe, Switzerland and UK.
- Excellent interpersonal and communication skills.
- Organised, analytical thinker with good attention to detail.
- Ability to resolve problems and to make appropriate regulatory decisions.
- Accountability for the achievement of key operational or functional goals.
- Ability to adapt to changing deadlines.
- Good computer skills (Advanced with Excel, Word, Outlook, PowerPoint).
Please note: This role is based in Enniscorthy, Ireland 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.
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Primary Work Location
IRL Wexford - EnniscorthyAdditional Locations
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."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
€75,900.00 - €115,725.00 EUR Annual
