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Regulatory Affairs Officer

Do you wish to be part of a business which expanding rapidly and manufacturing a Healthcare Product that is changing peoples lives for the better? This revolutionary Med Tech business is seeking a number of highly skilled people one of these is for a Regulatory Affairs Officer

You will be directly involved with the management of regulatory projects, including, but not exclusively, new product development, product life cycle and regulatory processes. There will be a focus on strategic planning and transitioning company products and processes to meet 2017/745 MDR.

DUTIES AND KEY RESPONSIBILITIES
Please provide a breakdown of tasks under the main areas of work.
• Manage companies transition to the Medical Device Regulation 2017/745.
• Prepare and maintain the Class I and Ila Technical Files in line with the regulatory requirements and Company Quality Procedures.
• Lead, manage, schedule and prepare Clinical Evaluation Plans and Reports (CER) in accordance with regulatory guidelines and Company Quality Procedures.
• To liaise directly with international regulatory agencies and provide supporting
documentation, handle queries and issues
• Offer general advice on regulatory strategy for new product developments, product re­-development and process changes
• To contribute to the development and implementation of regulatory policies, procedures
and specifications across the company and ensuring that these are compliant with the Quality Management System.
• To assist with the regulatory compliance of marketing communications/messages products
and services.
• Monitor changes in legislation, standards and guidance documents.
• Contribute to the development and implementation of regulatory policies, procedures and
specifications across the company and ensuring that these are compliant with the Quality Management System.
• To be responsible for planning own workload and works with limited input from the line
manager, influencing personal training and assisting in setting appropriate time lines for
projects.
• To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results
• Any other reasonable duties commensurate with the skills and responsibility of the post holder. I
• To promote and adhere to the workplace values of HWYL:
o Honesty, integrity and respect for others
o Willingness to accept challenges and responsibility
o Your commitment to our customers and business growth
o Learn and develop.


Qualifications, Skills and Experience

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