Regulatory Affairs Specialist - Medical Devices

About the Role

Our client seeks a meticulous and knowledgeable Regulatory Affairs Specialist to join their team in Belfast , focusing on medical devices. This critical role involves ensuring that the company's products comply with all relevant national and international regulatory requirements throughout their lifecycle. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory authorities, and providing guidance on regulatory strategies. This position is vital for facilitating market access and ensuring the continued compliance of innovative medical technologies in a complex global landscape.

Key Responsibilities

• Prepare and submit regulatory dossiers for new medical device registrations and product variations in various international markets (e.g., FDA, CE Marking).
• Interpret and apply global regulatory standards and guidelines (e.g., MDR, IVDR, FDA 510(k)).
• Act as a key contact point for regulatory agencies, responding to queries and managing inspections.
• Review product labeling, marketing materials, and technical documentation for regulatory compliance.
• Develop and implement regulatory strategies to support product development and commercialization plans.
• Maintain and update the company's regulatory compliance systems and documentation.

Requirements

• Bachelor's degree in a scientific, technical, or regulatory field.
• 3-5 years of experience in regulatory affairs, specifically within the medical device industry .
• In-depth knowledge of global medical device regulations (e.g., EU MDR/IVDR, FDA 21 CFR Part 820).
• Proven experience in preparing and submitting regulatory submissions.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple projects and deadlines effectively in a fast-paced environment in Belfast .

Benefits

• Competitive salary and annual bonus potential.
• Comprehensive benefits package including health, dental, and life insurance.
• Opportunities for international travel for conferences and meetings.
• Generous paid time off and company holidays.
• A stimulating work environment with a focus on compliance and innovation.