Omega Gloucester, England, United Kingdom
Regulatory Affairs Manager
Our client, a global leading manufacturer in the medical device industry, is on the hunt for a Regulatory Affairs Manager. Role and Responsibilities – In this role, you will ensure business compliance, regulations, and quality standards in support of the company's overall goal. This will be to maintain the correct market access for the device internationally. Other responsibilities include: Maintain up-to-date knowledge on both domestic and international regulatory requirements, effectively communicating to management and project teams. Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO14971). Issue advisory notices as required, in accordance with the MDD, MDR, and FDA regulatory requirements (21 CFR 803). Develop, prepare, and maintain high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals. Experience or Qualifications – Proven experience within regulatory affairs with an extensive amount being in a managerial position. Medical device experience is essential. Lead Auditor training. MDR experience strongly desirable. Benefits – 25 days annual leave + Bank Holidays. Private Health Care Options. Employee Assistance Programmes. For more information regarding this Regulatory Affairs Manager role, please contact Ben Herd on 01453 829523 or ben.herd@omegaresource.co.uk. Omega Resource Group is acting as an Employment Agency in relation to this vacancy. Seniority Level:
Mid-Senior level Employment Type:
Full-time Job Function:
Quality Assurance, Manufacturing, and Engineering Industries:
Industrial Machinery Manufacturing, Medical Equipment Manufacturing, and Manufacturing
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Our client, a global leading manufacturer in the medical device industry, is on the hunt for a Regulatory Affairs Manager. Role and Responsibilities – In this role, you will ensure business compliance, regulations, and quality standards in support of the company's overall goal. This will be to maintain the correct market access for the device internationally. Other responsibilities include: Maintain up-to-date knowledge on both domestic and international regulatory requirements, effectively communicating to management and project teams. Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO14971). Issue advisory notices as required, in accordance with the MDD, MDR, and FDA regulatory requirements (21 CFR 803). Develop, prepare, and maintain high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals. Experience or Qualifications – Proven experience within regulatory affairs with an extensive amount being in a managerial position. Medical device experience is essential. Lead Auditor training. MDR experience strongly desirable. Benefits – 25 days annual leave + Bank Holidays. Private Health Care Options. Employee Assistance Programmes. For more information regarding this Regulatory Affairs Manager role, please contact Ben Herd on 01453 829523 or ben.herd@omegaresource.co.uk. Omega Resource Group is acting as an Employment Agency in relation to this vacancy. Seniority Level:
Mid-Senior level Employment Type:
Full-time Job Function:
Quality Assurance, Manufacturing, and Engineering Industries:
Industrial Machinery Manufacturing, Medical Equipment Manufacturing, and Manufacturing
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