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We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO 13485 diagnostics product pipeline. Reporting to the Regulatory Affairs Manager, you will play a crucial role in ensuring regulatory compliance and supporting the successful submission of our products to global regulatory agencies.
As Regulatory Affairs Specialist responsibilities include:* Collaborate closely with the Regulatory Affairs Manager to develop and maintain technical files and submissions for global regulators.* Utilise your regulatory expertise to support the development of regulatory strategies for product submissions.* Analyse routes to market and provide relevant information to senior regulatory team members.* Assist in the development and maintenance of regulatory processes to meet pre and post-launch obligations.* Maintain accurate records related to regulatory procedures and filings.* Foster collaborative relationships across departments and support project teams effectively.* Contribute to the development and training of project teams in regulatory affairs.
Qualifications/Experience required:* Bachelor's degree in a science subject (e.g., molecular biology, biomedical sciences)* Two or more years of experience in regulatory affairs within the diagnostics or medical devices industry* Strong knowledge of FDA, EU regulations, ISO 13485, and ISO 14971* Excellent communication and writing skills* Strong team-working, analytical, and problem-solving skills* Ability to make decisions and escalate when necessary
Benefits: Outstanding benefits including an attractive bonus, generous pension contributions, private healthcare, and a competitive salary.
Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency
