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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Warsaw, Poland

Job Description Summary

Job Description

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 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The main Regulatory Affairs Specialist responsibility is to provide regulatory support to the BDX business in Poland and CEE. This will involve working with people from multiple segments and countries to progress the business and ensure that BD is compliant in an efficient and effective manner.

  • Developing, planning and executing Regulatory plans in accordance with the country-specific requirements

  • Ensuring technical documentation is correct, up to date

  • Supporting timely approval of premarket submissions/renewals of authorizations by understanding the local regulations and their practical interpretation

  • Supporting product registration activities for EU databases, Poland, and CEE databases

  • Anticipating regulatory impacts and emerging issues for the continued supply of product in the region and supporting the efforts of cross-functional teams

  • Ensuring that Competent Authority communications regarding Regulatory issues are responded to in a timely manner

  • Reviewing and approving promotional material and product labeling for the region to ensure compliance with local and corporate requirements

  • Providing RA support in responding to technical questions from customers, business units, tenders for BDX across Poland and CEE

  • Supporting customers by addressing their queries

  • supporting tenders with regulatory information

  • Ensuring distributors can access MDR mandatory regulatory information as per MDR requirements

Skills and capabilities of a successful candidate:

  • 3 - 5 years of experience in Regulatory Affairs, preferably in the Medical Device industry

  • Bachelor or master’s degree

  • Great interpersonal and communication skills

  • Willingness to work in detail oriented way and to seek improvements

  • You provide regulatory knowledge, e.g. guidelines, policies, principles, and requirements of applicable product laws/standards and Global Regulatory submission requirements

  • Great teammate

  • Proficiency in English and Polish

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.

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

Primary Work Location

POL Warsaw - ul. Osmanska

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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