Aktuelle Jobs im Zusammenhang mit Medical Device Regulatory Specialist - Neuenburg, Neuenburg - Sound United
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Medical Device Regulatory Specialist
vor 2 Monaten
Sound United is a dynamic and innovative company seeking an experienced Medical Device Regulatory Specialist to join our team. The ideal candidate will have expertise in medical device regulations, requirements, and standards, as well as excellent communication and organizational skills.
About the RoleWe are looking for a highly motivated and detail-oriented individual to support our regulatory affairs team with day-to-day projects and initiatives. This role involves preparing and coordinating country submissions for medical devices in EMEA, maintaining regulatory certificates and licenses, and supporting distributor registration activities.
Responsibilities- Regulatory Affairs Coordination: Assist in registrations to the MDD/MDR in the EU and national requirements, achieving company objectives and timelines in the EMEA region.
- Certificate Management: Maintain schedule for renewal of regulatory certificates and licenses, and process and maintain requests to support distributor medical device registration activities.
- Documentation and Record-Keeping: Update technical documentation taking into account regulatory requirements, maintain regulatory affairs files, and list and distribute information as required.
- Meetings and Project Support: Support scheduling and arrangements for regulatory meetings, and perform other duties or special projects as assigned.
- Regulatory Knowledge: Proficient in global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive, and Regulation (EU) 2017/745.
- Communication Skills: Excellent verbal and written communication skills, with ability to work effectively in a matrix environment with non-local and local leadership.
- Education: Bachelor's degree, or equivalent combination of education and experience, in science, engineering, medical/healthcare, or regulatory science.
- Experience: 2-5 years of related work experience, preferably within a medical device company, working as part of an international organization.
We offer a competitive salary range of $80,000 - $110,000 per year, depending on experience, plus benefits and opportunities for professional growth and development.
