Regulatory Affairs specialist EMA – BD Life Sciences
Job Description SummaryThe Regulatory Affairs Specialist BD Life Sciences, EMA, is reporting directly to the RA Manager EMA and is part of the RA EMEA BD Life Sciences department and the RA EMA team BD Life Sciences.
This position will mainly focus on providing regulatory support for BD Life Sciences products (IDS and BDB) in EMA in relation to product registration or tender requirements, ensuring products are being registered in a timely manner to market these in the selected countries in EMA. You will assess the impact of the EU regulations, EU IVDR and EU MDR on the product registrations in the EMA countries and ensure that the local regulatory requirements are met to market the products in the EMA countries
- Processes regulatory amendments and re-registrations in relation to existing product registration for BD Life Sciences products for the EMA region 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 Sales 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.
- Assembles technical information to create a "dossier" as needed.
- Maintains the EMA Registration 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.
- Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations and/or regulatory activities as needed
- Has an understanding or desires to obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices products and medical devices which may impact the BD Life Sciences Business in EMA
- Recognizes and proposes continuous process improvements.
- Manages small projects individually and provide support to other projects as appropriate.
- Provide other duties and assignments as required.
More about yourself:
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.
- Location: Erembodegem
Primary Work LocationBEL Erembodegem - Dorp 86
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