Regulatory and Quality Consultant

REPORTING TO: Technical Director

Key purpose:

• Provide expert UK/EU/US Medical Device Regulatory and Quality Management
  consultancy for Advena clients and advise prospective clients of Advena Ltd
• Maintain clients UK/CE Technical Files in order to ensure compliance to current
  regulations.
• Fully support the Technical Director and be an active member of the consultancy team.

Responsibility:

• Provide accurate and current medical device regulatory and quality management advice
  to Advena’s client base and prospective clients.
• Update or create technical/regulatory documentation for medical devices or in vitro
  diagnostic medical devices.
• Update or create quality management system documentation of any Advena client that
  follows the requirements of ISO 13485.
• Visit clients to conduct / assist with Management Review Meetings, internal / external
  audits, or other relevant regulatory requirement matters.
• Provide support to other members of the team and Technical Director, when requested.
• Oversee regular communication with clients to provide accurate and concise updates on
  regulatory changes that could affect their businesses.
• Ensure compliance with company’s QMS.
• Represent the company in a professional and courteous manner.
• Any other task as required by the Technical Director.

Qualification & Experience:

• Degree or equivalent certification in science related, medical, or engineering discipline.
• Experienced and knowledgeable of the medical device industry, both for medical device
  practical usages, their application and design, manufacturing and regulatory affairs, with
  at least 5 years’ experience.
• Experienced enough to verify technical, design and manufacturing information.
• Suitable general IT skills
• Quality Management System – ISO 13485 experience
• Risk Management ISO 14971 experience.
• Lead Internal Auditor to ISO 13485 and ISO 9001 standard preferable
• Experience in design and manufacturing processes.

If you believe you have a skill set that could add value to our team—even if there isn’t a specific role currently advertised—we’d love to hear from you. We’re always open to connecting with talented individuals who bring something unique to the table.