Location: Vaud Region, Switzerland Contract Duration: Starting April for 8 months. (potentially renewable) Type: Freelance/Contract Company Overview Our client is a leading company in the MedTech industry, dedicated to developing innovative products that meet the highest standards of safety, quality, and regulatory compliance. They are seeking a Senior QA Specialist on a freelance contract to support their growing team and ensure product quality and regulatory adherence. Job Description We are looking for a Freelance Senior Quality Assurance (QA) Specialist with a solid background in MedTech, FDA regulations, 510(k) submissions, Good Manufacturing Practices (GMP), and experience supporting clinical trials, particularly Clinical Phase II B. You will play a key role in maintaining high-quality standards, managing regulatory compliance, and ensuring the success of clinical trials and submissions. Responsibilities
Oversee and ensure compliance with FDA regulations, including 510(k) submissions for medical devices.
Support and review clinical trials, particularly in Clinical Phase II B, ensuring all QA requirements are met and properly documented.
Maintain and continuously improve GMP processes within the company.
Act as a liaison for regulatory bodies, ensuring timely and effective communication and compliance.
Mentor and provide guidance to junior QA team members, fostering a culture of quality and regulatory excellence.
Ensure all documentation is compliant with regulatory requirements, including technical files, risk management, and submission dossiers.
Key Qualifications
Proven experience in MedTech, especially within the Quality Assurance (QA) field.
In-depth knowledge of FDA regulations and 510(k) submissions.
Solid understanding of GMP standards and experience working in a regulated environment.
Demonstrated experience in clinical trial management, particularly for Clinical Phase II B trials.
Strong communication skills with the ability to work cross-functionally with various stakeholders.
Ability to work independently and handle multiple tasks with a high level of attention to detail.
Additional Information
This is a freelance/contract role based in the Vaud region, Switzerland.
Contract duration: Starting April, with a potential duration of [Number of months].
Competitive hourly rate based on experience.
How to Apply If you have a strong background in QA for MedTech, FDA 510(k) submissions, GMP, and clinical trials, we’d love to hear from you. Please send your updated CV and any relevant project experience to h.perret@panda-int.com