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Regulatory Affairs Specialist (m/w/d)

Datum:  09.09.2021
Standort: 

Aachen, NW, DE

Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives.   We have a single guiding mission:  “Patients First.”   With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical technology companies in the world.  Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development. 

 

 

 

Principal Duties and Responsibilities:

 

The Regulatory Affairs Specialist will be responsible for submissions in Europe and the Middle East, potentially including emerging markets in Eastern and South-East Europe and Africa, as needed as well as project team participation. The Regulatory Affairs Specialist will also act as a key liaison with the regulatory agencies as needed. 

 

  • Be passionate about regulatory affairs in support of the production of state-of-the-art medical devices
  • Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
  • Recognize the importance of building and maintaining strong interpersonal relationships
  • Understand the impact of global registrations and product commercialization
  • Develop and execute submissions for new products

 

Key Responsibilities:

 

  • Execute regulatory planning and ensure alignment with business and functional goals and priorities
  • Support development and implementation of regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives
  • Actively participate on project teams as assigned
  • Prepare Notified Body applications and other regulatory documents including Technical File / Design Dossier / STED submissions, Change Notifications and Periodic Medical Device reports as assigned
  • Prepare applications to international regulatory agencies
  • Conduct presentations and negotiations to agency reviewers as needed
  • Review and interpret regulatory rules as they relate to company products and procedures, testing or records keeping and ensure that they are communicated through company policies and procedures
  • Review and approve changes to manufacturing processes and products to ensure compliance with RA guidelines of assigned jurisdictions
  • Provide input to the product development and engineering teams to ensure that RA requirements are fully understood and mitigated as part of the product development and the engineering change process
  • Communicate regulatory project status to internal stakeholders
  • Follow changes of the regulatory landscape, identify impact to the company and develop solutions to maintain regulatory compliance

 

QUALIFICATIONS

 

  • Degree in engineering or science required, advanced degree preferred
  • At least 2 years of regulatory affairs experience with a cardiovascular device company preferred
  • Experience in submissions following the European Medical Device Directive 93/42/EEC or Active Implantable Medical Device Directive 90/385/EEC
  • First experience with transfer to the EU Medical Device Regulation 2017/745
  • Experience in regulatory submission preparation
  • Project Management experience preferred
  • Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
  • Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
  • Must be proficient in Microsoft Office Suite
  • Fluent in English and German

 

 

ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.