Fulltime
Vienna
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a Medical Device Development Manager (f/m/d).
About the Role: In this role, you will drive the clinical development and project management of medical devices, leading cross-functional efforts from early-stage development to market maturity. Collaborating with diverse teams, you will ensure compliance with regulatory standards while fostering innovation and excellence in clinical evaluation and technical documentation. Additionally, you will contribute to financial planning and oversee resource allocation to achieve project goals.
What Your Day To Day Will Look Like
1. Lead and manage activities for medical device development, ensuring successful progression from concept to market readiness.
2. Conduct comprehensive clinical evaluations, including planning, data appraisal, analysis, and reporting.
3. Perform systematic literature reviews to support clinical evaluations, post-market follow-ups, and protocol development.
4. Prepare and update Clinical Evaluation Reports (CERs) and summarize literature for regulatory and technical purposes.
5. Ensure compliance with MDR, ISO standards, and applicable regulations throughout clinical development.
6. Write regulatory documents for medical devices, adhering to GCP and European legislation.
7. Respond to global regulatory agency queries related to medical devices.
8. Support the creation and review of technical documentation, including user interface design, risk assessments, and clinical evaluations.
9. Manage project budgets, ensuring resource allocation aligns with financial objectives and supports cost control.
Your Qualifications and Experience
1. Degree in engineering, life sciences, or a related field; advanced degrees preferred.
2. 5+ years of experience in the medical device industry as a research engineer.
3. 2+ years of project management experience, preferably in the medical device or biotechnology industries.
4. Hands-on experience with stem cell handling, activation procedures, and related techniques.
5. Strong problem-solving and analytical skills, with the ability to navigate complex challenges.
6. Exceptional communication and interpersonal skills, capable of managing diverse teams.
7. Proven expertise in budget management, financial planning, and resource allocation.
8. Proactive attitude with a focus on delivering results.
Our offer
1. A position with personal responsibility and space for creativity.
2. Open corporate culture with the opportunity to bring in your own ideas.
3. Highly motivated, agile, and international team.
4. Great opportunities for personal and professional development.
5. Attractive work environment with excellent career opportunities and flat hierarchies.
6. Competitive salary package plus bonus and various benefits.
7. Gross monthly salary provided for this function is a minimum of EUR 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative",
Main Benefits
1. Yearly Bonus.
2. Take your focus when needed and stay connected.
3. Employee mobile phone.
4. Flexible working hours.
5. Company laptop.
6. Job training and further education.
7. Canteen on premises.
8. Good connection to public transportation.
9. Afterwork, Team and All-Company events.
10. Company doctor.
11. Parking spot.
HR Contact
Angelika Drabek
angelika.drabek@aop-health.com
AOP Health offers meaningful work that has an impact on the wellbeing of others. As a Vienna-based, global pharmaceutical company, we are looking for ambitious people with industry experience, who like to drive agile projects with cross-departmental alignment, and take on accountability.
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