Junior Regulatory Affairs

vor 12 Stunden

Heidelberg, Deutschland BD Vollzeit

**Job Description Summary**:
The main responsibility of this function is to provide regulatory support to the BDX business in Germany and CEE. Furthermore, the role will support the Heidelberg plant site with Regulatory Affairs issues in close collaboration with the US business. 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 include**:

- Developing, planning and implementing Regulatory plans in accordance with the country specific requirements
- Ensuring technical documentation is correct, up to date and available for EU AR and the commercial organization
- 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 on-site in Heidelberg 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 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 Germany and CEE
- Supporting the business unit and regional RA organizations with regard to Heidelberg products
- Supporting the IVDR Team in Heidelberg to align with IVDR and ensure registrations are performed on time with the BU/regional RA teams.
**Requirements & Qualifications**
- You have a bachelor or master’s degree in Science or Engineering as well as a minimum of 2 years Regulatory Affairs experience in the Medical Device industry, preferably IVD.
- You provide basic 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 challenging registration priorities.
- Furthermore, you are a strong teammate with a high internal customer service orientation.
- Fluency in German & English is a must, additional European language skills are preferred.

**Primary Work Location**:
DEU Heidelberg - Tullastrasse

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