May 10, 2022
Regulatory Affairs Manager - (based in Vienna, Austria)
We believe in a future where healthcare is more accessible. That’s the Bloom Vision and that's why we work with specialized, self-motivated minds to develop self-testing and home testing systems that combine diagnostics technology with medical knowledge and data.
We are searching for a Regulatory Affairs Manager who can ensure that Bloom Diagnostics is efficiently complying to applicable regulations and work closely with Product and Medical teams over the complete product lifecycle, focusing on premarket topics.
- Take ownership of all PreMarket processes (including a.o. Feasibility, R&D & Performance Evaluation)
- Ensure an efficient PreMarket setup being in compliance with all relevant regulations
- Operational responsible for TD maintenance & submission activities for our products
- Regulatory Feasibility, Market Approach Analysis & Execution for next products
- Act as regulatory liaison for development and medical in a network organization
- Lead for continuous process improvement projects
- Strong contribution in regulatory and quality compliance activities
- Mentor team members and consult other departments on regulatory affairs topics
- Setup internal trainings using our online learning management system for owned processes
- Act as internal Auditor
A little about you…
- 5+ years of regulatory affairs experience, with a focus on PreMarket and R&D related activities
- University degree or FH Master with a focus on science or medical engineering, quality management, medicine, pharmacy, law, or similar experience
- Knowledge of applicable US and EU in vitro diagnostics or medical device regulations required, knowledge of other markets is valued
- Experience in a diagnostic, medical device or pharmaceutical environment
- Technical understanding (Software, Electronics, Biotech) and affinity to working in a digital work environment
- Quality Management, Project & Process Management & Audit competencies & experience
- Fluent in English at a professional level; German and other languages are advantageous
- Well-organized and structured with a high level of attention to detail and accuracy
- Have a positive, resilient and result driven attitude, even when encountering challenges
- Comfortable working in a hybrid environment and both independently and in a team and within a fast-paced and flexible startup environment
- Must be eligible to work in Austria
A little about us…
Bloom is an international company, with home bases in Zürich and Vienna. We are closely affiliated with venture-capitalists in Europe and overseas. 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 we can offer you:
- Change the public perception of diagnostic testing at home
- Working in a next-generation healthtech company, building and scaling a market from anew
- Flexible working hours and home-office
- Fast growing startup heading for global product availability
- Flat-hierarchy, with an open communication style and feedback
- Team activities and outings (hiking, team retreats, etc.)
- Wellness and Mental Health Initiatives for all
- An international work environment with English as the working language
- Investment in your further education and learning
- Opportunity to contribute to a more prevention focused and patient centered future of the healthcare industry
For this full-time position, we offer a competitive, minimum yearly gross salary starting at 50.000€, negotiable, depending on your skills and experience.
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To apply, send us an email at email@example.com! 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. We look forward to receiving your cover letter and CV.
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