Compliance And Quality Assurance Consultant (Medtech)

TL;DR

Compliance and Quality Assurance Consultant (Medtech): Providing expert consulting and contract services to biotech and pharmaceutical clients with an accent on GxP compliance, QMS development, and regulatory oversight. Focus on managing complex quality projects, conducting audits, and ensuring adherence to international regulatory standards like FDA, EMA, and MHRA.

Location: Must be based in Sweden or the EU/UK (Hybrid/Remote flexibility available).

Company

hirify.global is a global consulting partner for the life sciences industry, providing end-to-end solutions across the product lifecycle to accelerate scientific breakthroughs and ensure regulatory compliance.

What you will do

• Manage and execute GxP compliance and quality assurance projects for diverse clients.
• Develop and maintain Quality Management Systems (QMS) and provide QA oversight.
• Conduct GxP audits and support regulatory agency action responses.
• Act as a Qualified Person (QP), Responsible Person (RP), or RPi for clients where applicable.
• Provide expert consultation on deviations, non-conformances, and CAPA implementation.
• Support business development by identifying client needs and contributing to marketing content.

Requirements

• Bachelor’s degree in a scientific discipline required (Master’s or PhD preferred).
• Minimum 5 years of relevant experience in quality assurance and GxP compliance.
• Recent auditing experience required (at least 5 audits performed in the past year).
• Professional proficiency in English required; one additional European language preferred.
• Deep knowledge of FDA, ICH, EMA, and MHRA regulations.
• Ability to travel as required for client projects.

Nice to have

• Registration as a Qualified Person (QP), Responsible Person (RP), or RPi.
• Experience with cell and gene therapy projects.
• Graduate degree (MSc or PhD) in a scientific discipline.

Culture & Benefits

• Commitment to diversity, equity, and inclusion in a collaborative work environment.
• Support for remote and hybrid working arrangements.
• Opportunity to work on high-profile drug and device programs.
• Focus on professional development and subject matter expertise.