Regulatory Affairs Manager

PROACT Medical Ltd is a fast-growing medical device company, specialising in airway management consumables and patient monitoring equipment. We are looking to employ a Regulatory Affairs Manager to oversee the application of the company's Quality Management System, to ensure compliance with the applicable requirements of the essential requirements of the Medical Devices Directive 93/42/EEC and Medical Device Regulations (EU) 2017/745.

Reporting directly to the QA Manager (or in that person's absence the Managing Director), the successful candidate will be responsible for implementing procedures to ensure the ongoing compliance of the company's ranges of Class I medical devices, with particular focus on the aspects of Clinical Evaluation Files, Post-Market Surveillance and Risk Management.
The position will be based at our head office in Corby, Northants, working as part of the Regulatory Affairs and Quality Assurance Department, with close ties to the product management, warehouse and customer service teams.
Main Responsibilities

Managing a hands-on plan of action to audit and improve Technical Files, prioritising the Company's own manufactured products. This will also involve overseeing and training as necessary other members of staff to assist in these tasks.

Documentation and implementation of improved procedures relating to technical file management, with specific emphasis on

Clinical Evaluation Files

Post Market Surveillance

Risk Management

• Ensuring compliance of devices to all applicable regulations.


• Drafting, maintenance and review of EC declarations of conformity for PROACT-manufactured devices.


• Maintain registration of PROACT Devices on applicable online databases (EUDAMED, DORS, FURLS).


• Monitoring the regulatory Landscape, notifying the Company of any relevant changes, and implementing changes as appropriate based on the scope of the Company's activities.


• Evaluating regulatory requirements for new markets and existing international distribution agreements (including FDA).


• Work with the Company's Directors and Managers and our IT team to develop and adjust our own internal software system (PROACT PORTAL) to allow the best and most efficient implementation of MDR and ISO13485:2016 requirements.


• Deputising for the QA Manager in their absence, assisting as necessary with the administration of the QMS.
  
  The following requirements should be supported by strong qualifications (preferably to degree level), or relevant working experience:


• Experience of working with Regulatory Affairs within the medical device industry is required, and knowledge of the current medical device regulatory frameworks EU MDR 745/2017, UK MDR SI 618/2002 & US FDA 21 CFR 820 is essential.


• Strong understanding of the requirements of ISO 13485:2016


• Experience drafting Clinical Evaluation Files in compliance with the guidance of MEDDEV 2.7/1


• Strong numeracy skills, with a focus on statistical analysis.


• Good computer skills - advanced understanding of Word, Excel and Outlook is essential. Knowledge of SQL query writing an advantage.


• Ability to liaise with colleagues, suppliers, customers and regulatory bodies professionally and diplomatically.


• Proven administrative and organisational skills.


Personal Qualities

• Ability to work on own initiative and in teams effectively.


• Keen attention to detail.


• Capacity to take on product knowledge and build relationships with suppliers, customers and colleagues.


• Willingness to adapt and respond to the varied requirements of a dynamic business.