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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
Regulatory Affairs Manager Location - West Midlands Our client is an established contract manufacturing organisation (CMO) providing services on a global scale. As a fully regulatory compliance facility, our client are able to provide technical innovation supporting with the formulation and development of novel cleaning products across many sectors. An opportunity has now become available for an experienced Regulatory Affairs Manager to join the company and undertake a leading role in product compliance with industry standards and regulatory requirements. The role: As the Regulatory Affairs Manager, you will be expected to utilise a deep understanding of regulatory processes gained from within the chemical industry. This will lead to successful delivery of the following responsibilities: Lead regulatory projects according to UK & EU Biocidal Product Regulations. Delivery of projects in line with timeframes and budgets. Ensuring products are compliant with GHS/CLP, detergent and cosmetic regulations. Support in the development of Regulatory strategies. Communication with national and international regulatory bodies to maintain knowledge of current requirements. Suitable Applicants: As a Regulatory Affairs Manager you will be expected to act as the Regulatory expert within the team, so a strong knowledge of RA principles and practices is essential. It would be expected for suitable applicants to have the following background: Significant industry experience in a Senior Regulatory Affairs role implementing regulatory strategy. In-depth knowledge of regulatory standards for Biocidal, GHS/CLP, detergent and cosmetic regulations. Experience working with Regulatory bodies both within the UK & EU Prior experience in developing and maintaining regulatory compliance documentation and technical files. MSc/BSc in a relevant scientific discipline Additional professional certifications in regulatory affairs would be beneficial. In return, our client offers a permanent position with a competitive salary based on relevant experience.