Regulatory Affairs Specialist (FDA)

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Regulatory Affairs Specialist (FDA) - Vienna Based

- 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:

  • Prepare regulatory submissions and processes for the US market
  • Review and approve engineering changes in alignment with regulatory requirements
  • 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 required
  • Support all company initiatives as identified by management in support of Quality
  • Help continue to build our management systems (QMS) and regulatory affairs
  • Ensure compliance with U.S. Food and Drug Administration (FDA) regulations in particular, as well as 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 and maintain regulatory documents for regulatory submissions including pre-submissions, 510(k)s, de-novo, technical files, DHF, DMR, device registrations and listings, and investigational device exemptions/clinical studies
  • Plan, 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 and train the team
  • Responsible for the establishment and day to day operations of Regulatory Intelligence for Bloom and assisting in communication of any trends or concerns to the overall Bloom team
  • Develop and lead efforts to establish integrated and sustainable Regulatory Intelligence strategies, processes, and activities for our products enabling a successful entry to the market and a sustainable existence once launched
  • Establishes the operational objectives and assignments for the Regulatory and QM team regarding US market clearance/approval
  • Drive progress on cross functional projects related to regulatory intelligence

A little about you…

  • 3+ years of regulatory affairs experience
  • University degree with a focus on science or medical engineering, quality management, medicine, pharmacy, law, or similar experience
  • Experience in a medical device, IVD, biotech or pharmaceutical environment preferred
  • Experience in 510(k) submissions and in communications with FDA
  • 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
  • Required work permit for working in Austria

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 Zurich. We are closely affiliated with venture-capitalists in Europe and Overseas. Our team has proven experience in the European health tech, 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:

  • Flexible work hours and ability to organise home-office days.
  • Flat-hierarchy, with an open communication style and feedback.
  • Team activities and outings (hiking, team retreats, etc.).
  • Working with an internationally diverse, young and dynamic team where English is the company language
  • Spacious office in 1st district Vienna (with awesome places to go for lunch and after work drinks), free coffee and tea and fruit
  • Yearly Vienna transit card.
  • An international work environment with English as the working language.
  • Opportunity to contribute to a future where healthcare will be more prevention-focused and patient-centered

Like what you read?

To apply, send us an email at recruitment@bloomdiagnostics.com! We look forward to receiving your cover letter and CV. 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, yearly gross salary starting upwards from 56,000EUR, negotiable depending on the level of experience and skill that you bring with you.

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

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