BD (Becton, Dickinson and Company) RA Specialist Nordics and Baltics in Helsingborg, Sweden
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 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
About the role
The main responsibility of this function is to provide regulatory support to the BDX business in the Nordic and Baltic countries. 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.
Main responsibilities will include:
Developing, planning and executing Regulatory plans in accordance with the country requirements.
Ensuring technical documentation is accurate, up to date and available.
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 as needed.
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 material and product labelling for the region to ensure compliance to local and corporate requirements.
Providing RA support in responding to technical questions from customers, business units, tenders for BDX across Nordics and Baltic countries.
Supporting customers by addressing their queries.
supporting tenders with regulatory information.
Ensuring distributors can access MDR mandatory regulatory information as per MDR requirements.
You have a bachelor or master’s degree in Science or Engineering as well as a minimum of 5 years Regulatory Affairs experience in the Medical Device industry, preferably IVD.
You provide deep regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards and Global Regulatory submission requirements, as well as basic Project Management experience, ideally with supporting new product developments and launches.
You provide a high self-motivation, professional communication skills as well as an organizational talent and attention for detail in a complex work environment with multiple and competing registration priorities. Furthermore, you are a strong team player with a high internal customer service orientation.
Fluency in English and Swedish are a must, additional Nordic language skills are preferred.
Click on apply if this sounds like you!
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
SWE Stockholm - Marieviksgatan
SWE Helsingborg - Rönnowsgatan
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.