Our client (location: north of Vienna), a well-known top-player in its market, is expanding its successful team: we are currently searching for an FDA-expert. In this business crucial role you will have the chance to build up a department and take over leadership responsibility in the forseeable future.
Regulatory Affairs FDA Compliance Manager (f/m/x)
CHALLENGING ROLE WITH THE POSSIBILITY TO WORK REMOTE!
YOUR FUTURE ROLE
- Responsibility to act as "the" inhouse-expert and be the first point of contact for FDA
- 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
- Develop regulatory strategies to 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
- Technical degree or life science degree or a comparable background acquired through trainings/certifications
- At least 5 years medical device industry experience in a regulatory affairs role in the EU and FDA
- Experience interfacing directly with the FDA is required
- Profound understanding and experience with PMAs
- Thorough understanding of medical device agency regulations: FDA's medical device regulation (21 CFR Part 820), CE, European MDD/MDR as well as working knowledge of applicable medical device standards. E.g.: ISO 13485, ISO 14971, ISO 10993, ISO 14630, ISO 15798, ISO 14155, others
- Experience with regulatory compliance processes, regulation and standards implementations
- Strong project management skills: organizational strength paired with implementation skills
- Leadership personality with excellent communication: able to influence & negotiate with different stakeholders internally & externally
- Independent, structured and result-oriented way of working
- High solution orientation, strong problem-solving and decision-making skills
- Willingness to travel
- Business Fluency in written and spoken English as well as a good knowledge of German
OUR CLIENT OFFERS
- 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
- Opportunity to develop into a technical expert- paired with a leadership role
- Stable department with a very good working atmosphere
For this full-time position the minimum gross salary starts at EUR 70.000 per year (excluding bonus). 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.