Job Description

Regulatory Affairs Specialist

We 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.

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