Regulatory Affairs specialist EU - IDS
Job Description Summary
The Regulatory Affairs Specialist IDS, EU, is reporting directly to the RA Manager Europe, BD Life Sciences and is part of the RA EMEA BD Life Sciences department and the RA EU team supporting BD Life Sciences. This position will mainly focus on providing regulatory support for IDS (BD Integrated Diagnostic Solutions) products in Europe/CEE and Israel in relation to the Medical Devices Directive , the In Vitro Diagnostic Medical Devices Directive and the MDR (Medical Device Regulation) and IVDR (In vitro Diagnostic Medical Device Regulation)
Key responsibilities include, but are not limited to
- Processes regulatory requests in relation to product registration or tender requirements for IDS products in EU/CEE and Israel and provides responses in a timely manner. Where applicable, requests are to be made through the applicable (i.e. eGPS) system;
- Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale Certificates and Certificates of Exportability. Interfaces hereto with applicable regulatory organization within BD or regulatory agencies directly;
- Interfaces with OEM's to collect specific registration information as needed;
- Provide input to the maintenance of the EU CE-databases;
- Coordinates and supports the provision of a variety of statements to help the business;
- Reviews and responds to internal and external customer requests for regulatory documents;
- Follows up on all required translations for labels and IFUs for the EU/CEE region;
- Develops and maintains departmental procedures (SOP's and work instructions) for European and international product registrations (CEE and Israel) and/or regulatory activities as needed;
- Has a good understanding or desires to obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices and medical devices which may impact the IDS Business;
- Recognizes and proposes continuous process improvements.
- Manages small projects individually and provide support to other projects as appropriate.
- Provide RA support in the IDS Label Approval Process for Europe
- Provide other duties and assignments as required.
Structured and self-organized, your strong planning, time management and prioritization skills are recognized, including your ability to multitask. Other skills include:
- Demonstrated self-starter, and highly motivated.
- Demonstrated analytical problem solving.
- Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
- Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
- Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; and effective interactions with technical personnel (scientific and legal).
- Orientation for detail work product, with emphasis on accuracy and completeness.
- Promotes a collaborative environment and removes obstacles to teamwork across the organization
- Ability to work in an international environment
- Travel: International travel up to 10%
- Education: Related degree level education required. Higher education is a plus.
- Licenses/Certifications: Industry/function specific certification preferred.
- Experience: 1-2 years or more related industry (e.g. life sciences) experience preferred.
- Competencies: Native level English proficiency, both written and verbal. Additional EU language is a plus. Computer literate.
If you are interested, please click the "Apply" button!
Primary Work LocationBEL Erembodegem - Dorp 86
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