Regulatory Specialist

We are partnered with an exciting firm who are looking to expand their regulatory function.

Position Overview:

As a Regulatory Specialist, you will be responsible for supporting and managing regulatory submissions and registrations for medical devices across global markets. This role is ideal for someone who understands the regulatory landscape and enjoys coordinating documentation and communication with internal teams and regulatory authorities to ensure timely approvals.

Key Responsibilities:

• Prepare and submit regulatory documentation for product registrations, renewals, and amendments in accordance with global regulatory requirements (e.g., EU MDR, FDA 510(k), Health Canada, TGA, etc.).
• Maintain up-to-date knowledge of international medical device regulations and standards relevant to product registration.
• Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing, etc.) to collect, compile, and verify technical documentation (e.g., technical files, IFUs, labeling, etc.).
• Track and manage the lifecycle of global registrations, including renewals, updates, and post-market requirements.
• Support communication with regulatory authorities, distributors, and third-party representatives regarding ongoing and new submissions.
• Maintain regulatory databases, records, and registration status reports to ensure transparency and audit readiness.
• Contribute to regulatory strategy discussions and risk assessments for new product development and market expansion.

Qualifications:

• Bachelor’s degree in life sciences, biomedical engineering, regulatory affairs, or related field.
• Minimum of 3–5 years of regulatory experience in the medical device industry, with hands-on experience in product registration.
• Knowledge of global regulatory frameworks (EU MDR, FDA, etc.) and technical documentation requirements.
• Strong understanding of ISO 13485, ISO 14971, and other relevant quality system and risk management standards.
• Excellent organizational, project management, and documentation skills.
• Strong written and verbal communication in English; additional language(s) a plus.
• Ability to manage multiple projects and deadlines in a fast-paced environment.

Preferred Experience:

• Experience preparing 510(k), CE Mark submissions, or other international dossiers.
• Familiarity with Notified Bodies and interactions with regulatory agencies.
• RAC certification or postgraduate regulatory training is a plus.