September 23, 2022
Regulatory Affairs Post Market Specialist - Vienna Based
Come and innovate for a medical technology company.
We believe in a future where healthcare is more accessible. That’s why we work with specialized, self-motivated minds to develop home testing systems that combine diagnostics technology with medical knowledge and data. To support the realization of this vision we are searching for an internationally-minded Regulatory Affairs Post Market 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, flexible and diverse environment. You will:
- Take ownership of all post market processes (including CAPA and Non Conformity Handling)
- Ensure an efficient Post Market Surveillance setup being in compliance with all relevant regulations
- Manage all incoming negative feedback and ensure filing of complaints
- Ensure timely and efficient processing of all negative feedback, complaints and adverse event reporting
- Take ownership of processing all non conformities and CAPA and ensure timely and efficient execution
- Provide Statistics on relevant post market data
- Support others teams in the execution of Post Market Clinical Follow up and other post market surveillance activities
- Interact directly with notified bodies and competent authorities, if so required
- Assist in regulatory compliance activities, including but not limited to notified body audits, FDA inspections, and other regulatory agency inspections and audits
- Support in the implementation of new regulations and take ownership of the post market processes to ensure them to be compliant
- Setup internal trainings for owned processes
- Act as internal Auditor
- Establishes the operational objectives and assignments for the Quality Management & Regulatory Affairs (QMRA) Team
- Take ownership of cross-functional regulatory projects & collaborate with the QMRA Team on cross-functional topics
- Maintain close communication with all departments and report regularly to the Management Team
A little about you....
- 3+ years of regulatory affairs experience, with a focus on post market 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 medical device regulations required, knowledge of other markets is valued
- Experience in a medical device, biotech or pharmaceutical environment
- Technical understanding (SW, HW, Biotech) and affinity to using SW tools
- Experience in managing complaints, adverse events, CAPAs and Non Conformities
- Experience in communications with notified bodies and competent authorities
- Audit experience
- Focused and result driven mindset
- Moderation Experience is advantageous
- Fluent in English and German at a professional level; other languages are advantageous
- Well-organised with a high level of attention to detail and accuracy
- Have a positive and resilient attitude, even when encountering problems or when things go haywire
- Comfortable working remote and both independently and on a team, within a fast-paced and flexible startup environment
- Required work permit for working in Austria
- Nice to have:
- Working experience in a clinical / diagnostic laboratory environment
- Working knowledge of ISO 13485, GMP, 21CFR820 and other recognized international quality system standards is a plus
- Experience with methods like SixSigma, Lean and similar is beneficial
- Project management experience, always aiming for efficient management and reaching of deadlines
A little about us…
Bloom is an international company, with home bases in Zurich and Vienna. 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:
- Flexible work hours and ability to organise home-office days
- Up to 20 remote home-office days per calendar year (within EU & Switzerland)
- Flat-hierarchy, with an open communication style and feedback
- Team activities
- Wellness and Mental Health Initiatives for all
- 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
- Opportunity to contribute to a future where healthcare will be more prevention-focused and patient-centered
For this full-time position, we offer a competitive, annual gross salary starting at €45,000, negotiable and is the very least we would pay, depending on your skills and experience.
Like what you read?
To apply, send us an email at firstname.lastname@example.org! We look forward to receiving your 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.
Your privacy is important to Bloom thus we comply with the General Data Protection Regulation (GDPR). When applying with us @bloom diagnostics we will process your personal data provided by you for the purpose of handling your job application on the legal basis of a pre-contractual relationship. In your best interest, to inform you of new job opportunities suited for you, we will keep your application data for 24 months. After that period we will delete it. If you do not want us to keep your application data, we will delete it earlier upon your instructions. If you have further questions regarding data handling, do not hesitate to reach out to us: email@example.com.