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Regulatory Affairs Specialist

4 months ago

Niles, United States ACL Digital Full time
THE OPPORTUNITY:
We are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist for a 9 month contract. We are seeking an experienced individual with a strong background in the medical device industry and extensive knowledge of the European Union Medical Device Regulation (EU MDR) 2017/745. 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.