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Consultant Medical Devices Regulatory / US submission expert

United States, Pennsylvania, PhiladelphiaMedical Devices

Job description

What you'll do

Currently, Qserve has an exciting opportunity to join our team as a Consultant Regulatory US. As a Qserve consultant, you serve a wide variety of clients in the medical device industry. With your regulatory knowledge of medical devices, you will be responsible for helping Qserve clients obtain US market access for a wide range of medical devices. You will be part of a team of medical device experts, working from across the world, dedicated to supporting our clients.

Job requirements

What you’ll bring to the team

The candidate we are looking for is a highly motivated and passionate Regulatory professional, who has experience in writing and reviewing US FDA submission files of medical devices (e.g. 510(k), IDE, PMA) and interactions with the Agency (e.g. Q-sub meetings, submissions, communications) . You have an in-depth understanding of US regulations and are able to engage a large variety of medical device technologies and help clients to achieve FDA approval. In this role, you thrive on variety and be able to manage multiple projects. We are a service-oriented organization so you must thrive on helping others. You like to write technical documentation and regulatory documents.


Your profile:

    • Technical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, physics, mechanical engineering, chemistry, (medical) biology, law, regulatory sciences/affairs, quality management or similar;
    • At least 4 years of working experience in the Regulatory Affairs for medical devices;
    • Strong knowledge of US Medical Device Regulations;
    • Knowledge of other medical device regulations is preferred (EU MDR, PAL, TGA, etc.);
    • Direct experience with writing technical documentation and regulatory documents for US submissions;
    • Experience with Medical device Quality management systems 21CFR820/ ISO 13485;
    • Self-starter;
    • Communicative and service-oriented;
    • Fluent in English;
    • Working permit and driver's license.

Interested?

Getting excited about a career in the dynamic and innovating world of medical devices?
Then we are looking forward receiving your application!

* This function will be executed remotely most of the time. We are open to candidates from all over the US.


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How we hire

We have a thorough and flexible hiring process, to ensure we make the right decision and to help you to decide if we're the right fit for you.

Screening

First of all, thank you for your interest in a career at Qserve. All applications are reviewed by our HR department in close cooperation with the respective hiring manager. If we see a potential match, you will be invited for a first interview.

Interview(s)

At this stage, we would like to take a deeper dive into your experience and what you could bring to the team. Besides that, we would love to tell you more about our company and people. You can expect several interviews with different relevant stakeholders.

Employment conditions

Are you ready to sign your contract? Our HR colleague is looking forward to informing you about the employment conditions at Qserve, both primary and secondary. Your adventure at Qserve Group officially starts here!

Onboarding

We know how important it is to provide new hires with an engaging onboarding and warm welcome. As part of the structured program, you will be introduced to representatives of all our global teams and departments.