Clinical-Regulatory Program Manager

vor 2 Wochen

Muri bei Bern, Schweiz Compremium AG Vollzeit

Job Overview

Compremium is seeking a skilled and highly motivated Clinical-Regulatory Program Manager to join our team. The ideal candidate will have a strong background in clinical and regulatory affairs within the medical device sector and experience in regulatory approval pathways with FDA and EU notified bodies. The successful candidate will ensure the compilation of pre-submission and submission packages, prepare pivotal clinical trials and support the continuous interaction with the regulatory authorities.

Join us in our journey and make a meaningful impact on the lives of patients and healthcare professionals

Contact

Please send CV and motivation letter to careers@compremium.ch

Job Responsibilities and Essential Duties:

  • Crafting regulatory submissions towards regulatory clearance of Compremium’s Class II medical devices in multiple regions, including Breakthrough Designations, FDA pre-subs, 510(k), CE-mark submission.
  • Crafting clinical trial submissions for multiple countries to provide strong evidence supporting regulatory clearance.
  • Support the continuous interaction with regulatory bodies, preparing interactive discussions, ensuring timely delivery of Q&A packages.
  • Perform all work in compliance with the relevant regulations, including ISO 13485, FDA, and EU MDR.
  • Provide training and support to staff on clinical and regulatory affairs.
  • Stay up to date with changes in regulatory requirements, guidelines, and industry best practices, and advise the organization on potential impacts.
  • Cross-functional collaboration: Collaborate with different stakeholders to contribute to company culture and growth.

Requirements:

  • Master’s degree in a related field (e.g., Biomedical Engineering, Life Sciences, Medicine).
  • Experience in the medical device field.
  • Experience in preparing and submitting regulatory documents and interacting with regulatory agencies (at least FDA and EU notified bodies).
  • Strong experience in designing and preparing medical device clinical trials in the US and Europe.
  • Strong understanding of medical device regulations and standards, such as FDA regulations (21 CFR), ISO 13485, and MDR.
  • Fast-learning.
  • Impeccable English; German and French working proficiency are a plus.
  • On-site (in Muri bei Bern) with the possibility of partial remote work.

Required Knowledge, Skills, and Abilities:

  • Minimum of 2 years of experience in clinical and regulatory affairs in the medical device industry.
  • Excellent understanding of medical device clearance processes with emphasis on regulatory submissions and clinical trials.
  • Detail-oriented with a commitment to maintaining high standards of quality.
  • Ability to manage time-critical projects.
  • Ability to work independently and as part of a team.
  • Excellent verbal and written communication skills.
  • Ability to work with internationally located collaborators.
  • Demonstrates passion and enthusiasm for the company’s vision and work.
  • Ability to adapt to a changing, fast-paced environment.

About Compremium AG

Compremium is a medical diagnostics company based in Bern, Switzerland. We are on a mission to transform the diagnosis of pressure-related conditions in the human body with our first-of-its-kind, non-invasive platform technology. The device is cleared by the FDA and is currently used by NASA in the International Space Station and other reputed institutions in the United States and Europe. We are in the process of launching our device in the United States, which is our first go to market, with a rapid expansion plan to scale quickly.

Seniority level

Entry level

Employment type

Full-time

Job function

Project Management and Information Technology

Industries

Medical Equipment Manufacturing

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