Regulatory Affairs Assistant (Hybrid) (1 Year
Job Description Summary**: The main responsibility of this function is to provide BDX regulatory support to the RA function in Italy and Greece, which may include registrations and notifications.
This will involve working with people from multiple BUs and countries to ensure that BD is compliant fulfills the regulatory requirements supporting the BDX business
**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 70, 000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
**Our vision for **Regulatory Affair** at BD**:
The Regulatory Affairs team is helping to ensure speed to market for BD's innovative medical technologies by having an acutely patient-centric attitude.
**About the role**:
**Main responsibilities will include**:
- Supporting product registration activities in the Repertorio (Ministry of Health database) of MD and IVD products (BDX) and data update including the EMDN classification, ensuring all product on the Italian market meets country regulatory requirements.
The registration process includes the following tasks:
- Collection of the registration data
- Consolidation of the data
- Registration in the MoH database
- Update of the information
- Support the data maintaining, including licenses records, in internal regulatory database(s) as required
- To support the review and approval of product promotional materials to ensure compliance with local and corporate requirements.
- To support the submission to the local Authorities of the authorization requests for advertising when needed
- Supporting the wider EU Regulatory Affairs team as required
- Providing RA support in responding to technical questions from customers, business units, tenders for BDX across Italy and Greece
**About you**:
- Bachelor's degree required, preferably in a scientific discipline such as Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology, etc.
- Preferably experience as Regulatory Affairs in medical device/diagnostic sector
- Comfortable working with people remotely.
- Understanding of both legal and scientific matters
- Well-developed analytical skills and the ability to pay particular attention to details
- Ability to work under pressure and to follow deadlines
- Integrity and a professional approach to work
- Proficiency in verbal and written English language
**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.
**Primary Work Location**: ITA Milano - Via Enrico Cialdini
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