Our client (location: north of Vienna), a well-known top-player in its market, is expanding its successful team: we are currently searching for a motivated personality, who has the ability to become their FDA-expert. In this business crucial role you will be trained externally to establish your FDA know-how and become a specialist in the foreseeable future.
Regulatory Affairs FDA Compliance Specialist/Manager (f/m/x)
WILL YOU TAKE THE CHANCE TO GROW INTO AN EXPERT ROLE?
YOUR FUTURE ROLE
- Responsibility to act as “the“ inhouse-expert and be the first point of contact for FDA
In parallel to your on-the-job-training you become gradually responsible for the following tasks:
- Plan and implement regulatory compliance training activities for company employees
- Ensure submission and approval as well as life cycle of the products to the FDA (up to class III)
- Review and write relevant standard operation procedures (SOPs). Assist with the design, update, and adherence to standard operating procedures to meet regulatory standards
- Support PMA and 510k processes. Support RD and CT department in the compilation of the technical dossiers and their submissions to the agency
- Prepare regulatory documents required for timely completion of regulatory submissions that include some or all of the following: pre-submissions, PMA, 510(k), IDE
- Provide regulatory guidance to the company throughout the product life cycle, assess variations and file amendments with the agency to keep PMA and 510k dossiers up to date as basis for product release. Prepare and submit yearly reporting to the agency and approval supplements. Maintain appropriate registrations and product listings
- Detect, read, interpret new and modified regulations, guidance, standards for new and current compliance procedures and monitor their implementation
- Specify and coordinate product and distribution related labelling requirements and regulatory release of labelling
- Review and regulatory release of marketing material for appropriate labelling and claims: IFU, internet, audio and video media. Collaborate with appropriate departments for developing applicable materials need to gain market clearance
- Advice marketing and distribution operations in distribution, advertising regulatory requirements in the light of product launch
- Support post-market corrective actions in cooperation with vigilance activities
JOB REQUIREMENTS
- Technical degree or life science degree or a comparable background acquired through trainings/certifications
- First working experience in the medical device industry, preferable in a regulatory affairs role
- Touchpoints and/or practical knowledge in interfacing with US FDA
- Aware of regulatory compliance processes, regulation and standards implementations
- Strong project management skills, good communicator throughout all business areas
- Independent, structured and result-oriented way of working
- Willingness to travel
- Business Fluency in written and spoken English as well as a good knowledge of German
OUR CLIENT OFFERS
- The chance to develop on-the-job into the FDA-expert-role
- Pragmatic ("hands-on") corporate culture with short decision-making processes and the opportunity to contribute and implement your own ideas
- Sophisticated product portfolio and a promising product pipeline
- Stable department with a very good working atmosphere
For this full-time position the minimum gross salary starts at € 50.000 per year. Depending on your skills and experience, our client offers a higher salary.
ARE YOU INTERESTED?
We are looking forward to receiving your application on our career portal: Our responsible consultant, Mrs. Nina Saurer, will get in touch with you after your application. We kindly ask you to support us in handling your application according to the GDPR regulation more effectively and apply through our career portal.