Senior Quality and Regulatory Lead

beBeeRegulatory; Badajoz; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A regulatory compliance firm is looking for a Quality and Regulatory Manager to oversee the Quality Management System for medical devices. The role involves ensuring regulatory compliance with various international standards and leading auditing processes. Applicants should have extensive experience in Quality Assurance, team management, and relevant educational qualifications. This is a remote position open to candidates across Europe.

Formación

• 5+ years in Quality Assurance or Regulatory assurance.
• 2+ years in team management.
• 10+ years in Health Science industry or related.

Responsabilidades

• Oversee all medical devices processes.
• Manage implementation of the QMS.
• Ensure QMS regulatory compliance.
• Lead internal and external audits.

Conocimientos

Quality Assurance

Regulatory compliance

Team management

Educación

Masters/Ph.D./B.Sc. (Hons) in life/natural sciences

Descripción del empleo

Overview

We are seeking a seasoned professional to fill the role of Quality and Regulatory Manager.

This position involves managing and maintaining our Quality Management System (QMS) for medical devices schemes. This includes overseeing all medical devices processes, ensuring alignment with global processes and accreditation requirements.

Responsibilities

• Own and oversee all medical devices processes.
• Supervise the implementation and maintenance of the QMS.
• Ensure impartiality and independence from commercial interests.
• Maintain QMS regulatory compliance to support designation and accreditation under MDR, ISO 13485, MDSAP, and other relevant schemes.
• Lead internal and external audits and ensure timely closure of corrective actions.

This role will report to the Head of Certification and Compliance, Business Assurance. The position is remote-based and open to candidates located across Europe who hold a valid work permit for their country of residency.

Requirements

• A minimum of 5 years\' experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organisation.
• 2+ year experience in team management.
• At least 10 years\' experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry.

Qualifications

• Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject.
• Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485.