Warszawa, mazowieckie

Job Description

The main Regulatory Affairs Specialist responsibility is to provide regulatory support to the BDX and BDI 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 and BDI 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

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.

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