Otto Bock Healthcare Products GmbH is an internationally leading medical technology supplier. Following our motto "Quality for Life", our aim is to provide people with the highest level of mobility and independence. We put people at the center of everything we do.
To strengthen our Global Regulatory & Risk Management Team in Vienna or Duderstadt we are looking to recruit at the earliest convenience a proactive and analytical thinking
Global Regulatory Affairs Specialist (m/f/d)
International Submissions (Jn 154917)
- Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe.
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintain regulatory files and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, Recognized Testing Laboratory certifications etc.
- Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
- Support approval in other regions as required.
- Communication with regulatory authorities for submissions, requests for additional information, update of submission files, pre-submission meetings.
- Definition of the regulatory strategies including classification, definition of the intended use, market access strategies and selection of suitable submission type.
- Perform risk management activities within assigned projects.
- Assist in preparing clinical trial site ethics review board applications for investigational device trials and prepare interim or final reports for trial site ethics boards.
- Review and create product labelling and review promotional material for compliance with applicable regulations and technical standards.
- Establish corporate subject matter expertise in submissions by writing SOPs about the submission/registration paths for the main product groups in the main markets.
- Stay up-to-date on regulatory procedures and changes in regulatory environment.
- Bachelor´s degree in Engineering or Science, higher degree is an advantage
- Minimum of 5 years of Regulatory Affairs or equivalent experience within a medical device company
- Proven experience in FDA submissions and CE certifications
- Risk Management (ISO 14971) knowledge and practical experience
- Profound knowledge of the global regulatory environment with focus on FDA submissions (510(k), DeNovo, PMA, BDP) and CE certifications (up to class IIb)
- Scientific knowledge and ability to digest complex data while keeping the big picture through good analytical skills.
- Attention to the details, structured and accurate way of working
- Excellent written and verbal communication skills with the ability to listen, articulate and advocate in German as well as in English
- Proactive, high performance and result oriented personality
- Technical system skills (e.g. MS office applications, databases, efficient online research)
- Ability to manage multiple projects and deadlines
- Demonstrate both creative and critical thinking skills
What we offer
- Actively contribute your expertise within a very successful and innovative company
- A motivated team that has real drive to improve on a professional as well as personal level
- A versatile and challenging job within an international environment that requires excellent intercultural skills
- Gross annual salary starting at EUR 53.000.- with willingness to overpay, depending on your qualification and previous experience
- A variety of social benefits (flexible working hours, job ticket, etc.)
We are looking forward to your online application.
Otto Bock Healthcare Products GmbH
Recruiting - Brehmstraße 16 - 1110 Wien