Regulatory Affairs Specialist - Medical Device

Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a Senior Regulatory Affairs Associate, you will play a crucial role in ensuring regulatory compliance for our medical devices. You will collaborate closely with the Regulatory Affairs Manager and cross-functional teams to prepare and review regulatory submissions, manage design dossiers, and facilitate compliance with global regulations. Key Responsibilities:

• Assist in the preparation and review of design dossiers, technical files, and Product Approval Certificates.
• Prepare regulatory submissions for product approvals in various markets.
• Manage documentation related to Custom Made devices, Special Products, and change assessments.
• Participate in Design Control, Risk Management, and Post Market Surveillance activities.
• Ensure compliance with the Vigilance System and regulatory requirements.
• Update and review Instructions for Use (IFU), Packaging, and Labelling materials.
• Perform other duties as required by the Regulatory Affairs department.

• Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering).
• Regulatory experience within the medical device or pharmaceutical industry is preferred.
• Familiarity with Class 3 Medical devices is advantageous.
• Strong understanding of global regulatory requirements and standards.
• Excellent communication and collaboration skills.
• Detail-oriented with the ability to manage multiple tasks effectively.
• Proactive attitude with a commitment to quality and compliance.

• Opportunity to make a meaningful impact on patient care through regulatory compliance.
• Collaborative and supportive work environment where your contributions are valued.
• Professional development and growth opportunities within a leading healthcare company.
• Competitive compensation package and comprehensive benefits.