Senior Regulatory Affairs Specialist

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 1,000 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 Senior Regulatory Affairs Specialist will be responsible for submissions under the European Medical Device Regulation (MDR); the Specialist will also support submissions to countries oriented towards CE marking (e.g. Eastern Europe, UK, CH, Middle East, APAC) as needed as well as project team participation. - 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 **Key Responsibilities**: - Review and approve all changes to manufacturing processes and products to ensure compliance with RA guidelines of assigned jurisdictions - Actively participate on project teams as assigned - Support regulatory planning and alignment with business and functional goals and priorities - 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 - Support development and implementation of regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives - Conduct presentations and negotiations to agency reviewers as needed - 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 support development of solutions to maintain regulatory compliance **QUALIFICATIONS** - Degree in engineering or science required, advanced degree preferred - At least 5 years of regulatory affairs experience with a cardiovascular device company preferred - Solid experience and proven track record in successful submissions following the European Medical Device Directive 93/42/EEC or Active Implantable Medical Device Directive 90/385/EEC - Experience with transfer to the EU Medical Device Regulation 2017/745 - Ideally experience in successful global submission preparation and execution - Exhibited strong project management and leadership skills - 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 - Ability to act independently to determine methods and procedures - Must be proficient in Microsoft Office Suite - Fluent in English and German **We offer**: - Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives" - Comprehensive induction program with structured onboarding plan throughout the orientation phase - Company pension allowance of up to 1,500 euros per year and capital-forming benefits - Abiomed shares at a preferential price - Benefit packages for occupational disability insurance and company group accident insurance - Full cost coverage for a job ticket in the Aachen or Berlin area - Various health programs and a leasing option for a job bike 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.