Regulatory Affairs Specialist

Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist for a 9 month contract. You will work with cross-functional teams to provide technical regulatory leadership and guidance to support new product development as well as existing product platforms. Sibel's fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative strategies, strong communication skills, teamwork, and more. What You Will Be Working On: Performing a gap analysis from FDA submissions to the technical documentation needed for EU MDR. Interacting with the notified body during technical documentation review and audits and responding to additional information requests. Creation and maintenance of templates and documentation needed for EU MDR for Sibel's products. Work closely with cross-functional teams, including R&D, Software, Hardware, Quality Assurance, and Clinical Affairs to provide regulatory guidance and support regarding EU MDR compliance during development of products. Evaluate current and upcoming changes in regulations in the European Union to determine and communicate impact to existing or proposed products. Review and update product labeling and instructions for use to ensure compliance with EU MDR regulations. Develop work instructions and procedures to ensure compliance with EU MDR requirements About You: Bachelor's degree in a scientific discipline, such as engineering, biological sciences, or a related field. Minimum of 7 years of experience in the medical device industry, with at least 3 years of direct experience working with EU MDR 2017/745. Experience working with software medical devices and vital signs monitoring devices preferred. Strong understanding of medical device classifications, risk management principles, and conformity assessment procedures. Proven track record of successfully managing and supporting regulatory submissions, including CE marking applications and Technical Files. Excellent analytical and problem-solving skills, with the ability to interpret complex regulations and provide practical solutions. Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.