Regulatory Affairs Specialist

Key Responsibilities

• Contribute to the development and maintenance of regulatory strategies for both existing and new medical device products, including Class IIb devices.
• Support regulatory project activities in collaboration with cross-functional teams, including R&D, Clinical Affairs, Quality, and Manufacturing.
• Provide regulatory guidance and technical expertise to internal stakeholders on product compliance and regulatory requirements.
• Assist in preparation for regulatory inspections and external audits, including supporting technical documentation reviews for FDA and ISO assessments.
• Work alongside Notified Bodies and support global product registrations, submissions, and regulatory approvals.
• Ensure products remain compliant with applicable regulatory frameworks, quality standards, and internal procedures.
• Follow Quality Management System requirements and support adherence to site EHS policies and procedures.
• Participate in communications with regulatory authorities, Notified Bodies, and other external agencies as required.

Requirements

• Bachelor's degree in a scientific discipline such as Life Sciences, Biology, Chemistry, or a related field.
• Proven experience with Class IIb medical devices is essential; exposure to combination products is highly desirable.
• Previous Regulatory Affairs experience within the medical device, diagnostics, pharmaceutical, or healthcare manufacturing industry.
• Strong understanding of ISO 13485, MDR 2017/745, IVDR 2017/746, MDD, IVDD, EMC requirements, and FDA Quality System Regulations (QSR).