Job Description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Following a new opportunity, we are currently looking for a Medical Device Senior Consultant based in Buffalo, New York, US .

The mission of this role will be to contribute to PQE's growth in the US Market, and to support global clients with US regulatory and quality projects. The role is expressly dedicated to Medical Device industry and involves active coordination across teams therefore it demands exceptional inter-personal skills as well as extensive knowledge of Medical Device Regulatory requirements.

Responsibilities:

• Provide technical oversight of local and global Medical Device Regulatory projects in accordance with standards and regulations such as: FDA QSR, EU MDR & IVDR, ISO 13485, ISO 14971, ISO 10993, ISO 27001, IEC 62366, IEC 62304, and more
• Lead or assist with identification of applicable regulatory standards and regulations, as applicable to various Medical Devices, including classification identification, regulatory pathways to market, and submission requirements
• Participate in Design Control projects to advise responsible personnel on regulatory requirements & development options
• Develop regulatory strategies by continually assessing project output and impact to regulatory framework
• Manage or assist with applicable Medical Device testing, performance testing and/or validation testing, as requested
• Lead or support registrations and submissions to applicable regulatory authorities. Submission types may include, but are not limited to: 510(k), PMA, De novo

About you:

• 8+ years of regulatory experience in the Medical Device industry
• Highly self-motivated and self-directed
• Ability to lead client calls/projects
• Understanding of Quality Management System requirements, risk management principles, regulatory requirements, and industry best practices with respect to medical devices
• Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner
• Ability to work under pressure and flexibility to adapt to changing priorities
• Effective English communication: writing and verbal
• Project Management experience; timeline and budget control

Work Location: Buffalo, New York, US

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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