Senior Regulatory Affairs Specialist - Aachen, Deutschland - Abiomed

Abiomed

Geprüftes Unternehmen

Aachen, Deutschland

vor 1 Woche

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts.

Saving lives." With 1,800 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.

Responsibilities:

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 stateoftheart medical devices
Be energized by working for a worldclass manufacturer and collaborating on crossfunctional 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
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

QUALIFICATIONS

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

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 capitalforming 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.