About Us
QES Medical is a leading consulting firm specializing in regulatory compliance and quality assurance for the medical device and pharmaceutical industries. We are dedicated to assisting our clients in navigating the complexities of regulatory frameworks across the US, EU, and global markets, ensuring their products meet all necessary requirements for successful market access.
Responsibilities
The key responsibilities of this role include, but are not limited to, the following:
Regulatory Guidance: Provide comprehensive advice on EU MDR requirements and assist clients in understanding their obligations under the regulation.
Documentation Review: Review and assess technical documentation, including Clinical Evaluation Reports (CERs), Risk Management Files, and Quality Management System (QMS) compliance.
Compliance Strategy: Develop and implement regulatory strategies for clients to achieve CE marking and market entry in the EU.
Training and Support: Conduct training sessions and workshops for clients on EU MDR requirements and best practices.
Client Liaison: Act as the primary point of contact for clients regarding regulatory inquiries and compliance issues.
Audit Preparation: Assist clients in preparing for audits by Notified Bodies and regulatory authorities, ensuring all necessary documentation is in place.
Stay Updated: Monitor changes in regulations, standards, and guidelines relevant to medical devices and provide clients with timely updates.
Commitment: Ability to work approximately 10-20 hours per week (remote work is allowed).
Main project duration is 3-6 months. Additional projects may be available upon completion of main project.
Qualifications
Education: Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred.
Experience: Minimum of 10 years of experience in regulatory affairs or compliance within the medical device industry, with a strong focus on EU MDR.
Knowledge: In-depth knowledge of EU MDR, ISO 13485, and related regulatory frameworks.
Skills: Excellent analytical, communication, and interpersonal skills; ability to convey complex regulatory concepts clearly.
Certifications: Relevant certifications (e.g., RAC, CQE) are a plus.
How to Apply
Interested candidates are invited to submit their resume and a cover letter outlining their relevant experience to admin@qesmedical.com, using the subject line “QA Consultant / EU MDR” by November 1st 2024.
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