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Regulatory Affairs Manager

2 months ago

Corby, Northamptonshire, United Kingdom PROACT Medical Ltd (UK) Full time
Job Description

Job Title: Regulatory Affairs Manager

Salary: £40-55k, dependent upon experience

Hours: Monday-Thursday 9:00-5:00; Friday 9:00-4:00. Full time Permanent Role, 37.5 hours per week

Company Overview: PROACT Medical Ltd is a leading medical device company specializing in airway management consumables and patient monitoring equipment.

Job Summary: We are seeking a highly skilled Regulatory Affairs Manager to oversee the application of our Quality Management System, ensuring compliance with the applicable requirements of the Medical Devices Directive 93/42/EEC and Medical Device Regulations (EU) 2017/745.

Main Responsibilities:

  1. Technical File Management: Manage a hands-on plan of action to audit and improve Technical Files, prioritizing our own manufactured products. Oversee and train other staff to assist in these tasks.
  2. Procedure Development: Develop and implement improved procedures relating to technical file management, with specific emphasis on:
    1. Clinical Evaluation Files
    2. Post Market Surveillance
    3. Risk Management
  3. Regulatory Compliance: Ensure compliance of devices to all applicable regulations.
  4. Declaration of Conformity: Draft, maintain, and review EC declarations of conformity for PROACT-manufactured devices.
  5. Database Management: Maintain registration of PROACT Devices on applicable online databases.
  6. Regulatory Monitoring: Monitor the regulatory landscape, notify the Company of any relevant changes, and implement changes as appropriate based on the scope of the Company's activities.
  7. Market Evaluation: Evaluate regulatory requirements for new markets and existing international distribution agreements.
  8. System Development: Work with the Company's Directors and Managers and our IT team to develop and adjust our internal software system to allow the best and most efficient implementation of MDR and ISO 13485:2016 requirements.
  9. Deputy QA Manager: Deputize for the QA Manager in their absence, assisting with the administration of the QMS.

Qualifications & Experience:

The following requirements should be supported by strong qualifications (preferably to degree level), or relevant working experience:

  1. Regulatory 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.
  2. ISO 13485: Strong understanding of the requirements of ISO 13485:2016
  3. Clinical Evaluation Files: Experience drafting Clinical Evaluation Files in compliance with the guidance of MEDDEV 2.7/1
  4. Numeracy Skills: Strong numeracy skills, with a focus on statistical analysis.
  5. Computer Skills: Good computer skills – advanced understanding of Word, Excel, and Outlook is essential. Knowledge of SQL query writing is an advantage.
  6. Liaison Skills: Ability to liaise with colleagues, suppliers, customers, and regulatory bodies professionally and diplomatically.
  7. Administrative Skills: Proven administrative and organizational skills.

Personal Qualities:

  1. Initiative: Ability to work on own initiative and in teams effectively.
  2. Attention to Detail: Keen attention to detail.
  3. Product Knowledge: Capacity to take on product knowledge and build relationships with suppliers, customers, and colleagues.
  4. Adaptability: Willingness to adapt and respond to the varied requirements of a dynamic business.