Regulatory Affairs Specialist

Regulatory Affairs Specialist 1920 534 bloom diagnostics

– for medical technology company with in-vitro diagnostic devices.

We believe in a future where healthcare is more accessible. That’s why we work with specialised, self-motivated minds to develop home testing systems that combine diagnostics technology with medical knowledge and data. To support the realisation of this vision we are searching for an internationally-minded Regulatory Affairs Specialist to join our growing team.

A little about your future role…

We offer a permanent position, based in Vienna, where you can grow professionally in an innovative, open, and future-oriented startup environment. You will:

  • Assist in the preparation of regulatory national and international submissions
  • Review and approve engineering changes
  • Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines and standards
  • Interact directly with FDA and other regulatory agencies, if so directed
  • Preparation and maintenance of regulatory documents for regulatory submissions
  • Support all company initiatives as identified by management in support of quality
  • Help build our quality management systems (QMS) and regulatory affairs
  • Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, national and international regulations and other regulatory requirements
  • Work with the Head of Regulatory Affairs to determine effective regulatory pathways for a variety of projects and issues
  • Prepare document packages for regulatory submissions including 510(k)s, technical files, device registrations, and investigational device exemptions
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
  • Assist in regulatory compliance activities, including but not limited to notified body audits, FDA inspections, and other regulatory agency inspections and audits
  • Study regulatory and legal documents, including relevant technical standards and guideline documents

A little about you…

  • 1+ years of regulatory affairs experience
  • University degree with a focus on science or medical engineering
  • Business administration, quality management, legal, or similar experience
  • Experience in a medical device, biotech or pharmaceutical environment preferred
  • Knowledge of applicable US and EU medical device regulations required, knowledge of other markets is valued
  • Experience with Software as a Medical Device and knowledge of implementing software under ISO 13485:2016, ISO 62304:2006 and FDA 21 CFR Part 820 preferred
  • Fluent in English at a professional level; German and/or other languages are advantageous
  • Well-organised with a high level of attention to detail and accuracy
  • Efficient project management is your second nature
  • Have a positive and resilient attitude, even when encountering problems or when things go haywire
  • Comfortable working both independently and on a team, within a fast-paced and flexible startup environment

Don’t have experience with all the points above?

Don’t worry, we are big fans of learning, training and coaching on the job. Shoot us an email and explain how we can help each other grow.

A little about us…

Bloom is an international company, with home bases in Vienna and Zürich. We are closely affiliated with venture-capitalists in Europe and the US. Our team has proven experience in the European healthtech, home-testing and medical research sectors and a proven track record of resilience in the competitive startup scene.

We value self-motivation and self-awareness, entrepreneurship, long-term thinking and collaborative teamwork. We are in the healthcare space and this requires us to constantly reflect upon how we impact the lives of our users. After all, we care for their health.

What you can expect:

  • Opportunity to make a positive impact on the healthcare industry
  • Flexible work hours and ability to organise home-office days
  • Perks such as gym membership and yearly transit card
  • Investment in your further education and learning
  • International work environment with English as the working language
  • Team activities and outings (hiking, team retreats, etc.)
  • Networking opportunities at startup events and conferences
  • Open communication and feedback

Like what you read?

To apply, send us an email at recruitment@bloomdiagnostics.com! We look forward to receiving your CV and references from your most recently held positions. We are proud of our diverse and international team and are an equal opportunity employer, meaning we don’t discriminate in our hiring based on age, gender, race, or anything else.

Salary

For this full-time position, we offer a competitive, monthly gross salary starting at 2.900€, negotiable depending on your level of experience and skill. We want you to participate in our company’s success: this is why we also offer equity options to our team members.

Annotation: *According to the Federal Collective Bargaining Agreement (Rahmenkollektivvertrag für Angestellte im Handwerk und Gewerbe: www.wko.at), this job is listed within class IV-1.

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