Regulatory Affairs Manager Freelancer (mfd)
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Lets build a healthier future together! By combining our unique strengths we are redefining healthcare through sustainable action and innovation. For a behind-the-scenes look check out this video to see how we at Roche are making personalized health care a reality.
The mySugr GmbH was acquired by Roche in 2017 and our Vienna office is one of Roches global sites. You will be located here in the heart of Vienna no matter if you work on a mySugr Accu-Chek navify or any other Roche product or solution. You can read more about the history of mySugr & Roche here.
Heres what were looking for:
Working hours: 30 - 385 hrs per week
We are looking for a Regulatory Manager Freelancer with experience in the area of Medical Device regulations. Our software apps are updated every other week thereby requiring lean and effective regulatory processes. As we are often pioneers in our field we need a pragmatic person who is eager to expand into new fields of products and services. mySugr currently has class IIa and IIb products on the market and is ISO13485 MDR and MDSAP certified; as a Regulatory Manager Freelancer you will support our product development activities and ensure regulatory compliance.
Essential skills for your mission:
More than 5 years professional experience with current EU and/or FDA Medical Device regulations and guidelines
Professional experience with ISO standards for Quality Management Risk Management and Software development
Professional experience with class IIa IIb and/or 510k Medical Device registrations
Experience in audits by Authorities and/or notified bodies
Experience in working on overlapping projects - i.e. good at juggling multiple projects multitasking and organizing yourself
Experience in optimising existing processes to work for multiple regulatory jurisdictions and at the same time minimising impact on daily work as far as possible
Excellent written and verbal communication skills in English
Enjoy learning new things
Willingness to working in cross functional fast-paced corporations
Bonus skills:
Knowledge of the diabetes industry or other comparable health industries
Technical understanding and love for innovative apps or software development
Experience working in agile environments
What to expect:
Ambitious and passionate people building meaningful products for a global audience
An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams
A growing organization with room for development
Who we are and what we care about
We are committed to providing a healthy equal and inclusive working environment for our employees to bring true relief to the patient! We care about family friendly career paths sustainability a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing as well as open and candid feedback. At every level there are many opportunities to develop and grow - both professionally and personally.
As a healthcare pioneer committed to transforming the lives of billions of people around the globe we push boundaries to redefine what is possible. We know that early accurate diagnosis is essential to maintain health prevent disease and help advance new targeted treatments and potential cures for the worlds most serious health problems. We have a passion for innovation and a profound commitment to make a lasting impact on society by continuing to improve the standard of care for humankind. Our culture inspires us to create healthcare that is sustainable efficient and financially viable. Healthcare that is built on peoples needs strong data and clinical insights. Healthcare that saves lives.
Interested Great. Wed like to hear from you! Just click that Apply Now button and send us your CV in English . and anything else that you think might impress us.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
