ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts.
Saving lives." With more than employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore.
Abiomed is part of Johnson & Johnson MedTech.
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.
Overall Purpose of Job.
Acting as RA lead and Management Representative for Abiomed China Provide regulatory leadership and regulatory decisions as Marketing Authorization Holder Lead Abiomed China regulatory strategy, provide strategic oversight for innovation Responsible for regulatory compliance of RA owned process Represent the voice of global regulatory and compliance on all Abiomed MD matters Active participate in local external/ regional regulatory shaping activities Key responsibilities.
As a member of APAC Abiomed RA leadership team, this role works with regional RA leadership team to drive regional G&O and Abiomed China commercial strategies.
Functional and Technical Competencies Leverages deep knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to develop and oversee the execution of compliant Regulatory strategies that are aligned with business objectives of the company.
Maintain extensive scientific and technical expertise as a subject matter expert in registering active, implantable medical devices in the relevant therapeutic areas Maintain understanding of medical device development methodology, marketing and market access concepts, health care reimbursement to be able to collaborate with business partners.
Encourages and leads others to find ways to continuously improve, learn about new scientific, technological and Regulatory developments, develop new capabilities, and learn from past challenges and experience in order to proactively adapt to change and drive innovative thinking.
Overall manages Abiomed strategies by acquiring and coordinating needed resources.
Assesses the financial implications of regulatory activities on critical business results for the organization.
Leverages in-depth knowledge of the sector, organizational vision, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies.
Leverages knowledge of the healthcare environment and external marketplace.
Leadership Competencies Advises and challenges others to ensure the best business-level decisions are consistently made within the organization and based on the Credo.
Quickly and effectively prioritizes critical Regulatory Affairs goals/ initiatives and manages resources in difficult, complex, or crisis situations.
Leverages a strong understanding of different perspectives and tailors influencing approaches accordingly.
Creates compelling negotiating positions that build support and consensus among key stakeholders.
Challenges the positions of others to reach win-win outcomes.
Grows and develops team in leadership, technical and future capabilities and competence to support business.
Qualifications A minimum of a bachelor’s degree in a scientific/engineering field is required.
Graduate degree is preferred Regulatory and policy professional with 10+ years of relevant experience in medical devices, pharmaceutical industry, preferable minimum 3 years in regulatory leadership roles, with experience in other functions roles such as government affairs, quality, medical affairs.
Deep knowledge of medical device industry and MD regulations.
Proven experience in leading regulatory policy shaping and discussions with regulatory authorities and the affiliated test labs.
Experienced in driving industry regulatory projects as a lead.
Cardiovascular device experience preferred Strong project and team management skills required.
Excellent communication, strong interpersonal, influencing and organizational skills.
Ability to collaborate with cross-functional partners/teams.
Strong sensitivity for dynamic and multi-cultural environments.
Experience preferred from a multi-national or regional company.
Experience with international regulations Proven analytical abilities Fluent in both verbal and written English