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Medical Devices Regulatory Consultant / US Submissions Expert

RemoteUnited States, Pennsylvania, PhiladelphiaMedical Devices

Job description

Our team enthusiastically commits themselves every day to assist customers in meeting the specific regulations, getting products approved, assisting with clinical studies, taking care of the registration process, while achieving and maintaining compliance all over the world. We strive to do this through our practical approach.


What you'll do

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.


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 are able to manage multiple projects. You like to write technical documentation and regulatory documents. We are a service-oriented organization, so helping others is your mindset.

Job requirements

  • 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 US Regulatory Affairs for medical devices;
  • Strong knowledge of US Medical Device Regulations; including recent changes and developments
  • 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
  • Self-starter;
  • Communicative and service-oriented;

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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.