Senior Regulatory Affairs Specialist (m/f/d) - APAC (Remote or Office)
Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore.
Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.
The Senior Regulatory Affairs Specialist (m/f/d) will be responsible for product submissions to Regulatory authorities in Asia, primarily to the Chinese NMPA. This includes Abiomed internal work, e.g., participation in project teams, training of other departments and advice to the management. The Senior Regulatory Affairs Specialist will also act as a key liaison with the local consultants and partners as needed.
- Be passionate about regulatory affairs leadership in support of the production and distribution of state-of-the-art medical devices
- Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
- Understand the impact of global registrations and product commercialization
- Develop and execute regulatory submission strategies for existing and new products throughout the product lifecycle that are consistent with business unit goals and objectives for the area of responsibility
- Drive regulatory planning for the assigned market (focus: China) and ensure alignment with business and functional goals and priorities
- Prepare and review regulatory applications and other regulatory documents including STED submissions, Change Notifications and Periodic Medical Device reports as assigned
- Present to and negotiate with consultants and, where applicable, agency reviewers as needed
- Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
- Provide input to the product development and engineering teams to ensure that International RA requirements are understood, and submission and marketing risks mitigated as part of the product development and the change process
- Follow changes of the regulatory landscape in assigned countries (through consultants, where applicable), identify impact to the company and develop solutions to maintain regulatory compliance
- Degree in engineering or related science required, advanced degree preferred
- Several years of regulatory affairs experience; with a cardiovascular device company preferred
- Solid experience and proven track record in successful submissions to regulatory agencies in Asia, ideally NMPA
- 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
- Fluency in English and German is a plus
- 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
- 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.