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Regulatory Affairs Group

[MedTech] RA Project Manager - Abiomed

  • Titel [MedTech] RA Project Manager - Abiomed
  • Funktion Regulatory Affairs Group
  • Unterfunktion Regulatory Affairs
  • Kategorie Senior Analyst, Regulatory Affairs (P6)
  • Standort Yongsan-gu, Seoul, Korea, Republic of
  • Gepostet
  • Stellenangebotsnummer 2406170636W


Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

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 2,000 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.

  1.  포지션: RA Project Manager - Abiomed
  2.  계열사: 존슨앤드존슨 메드테크 (MedTech)
  3.  근무지: 서울시 용산구
  4.  근무 형태: Regular


Coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules of new product registration, changes in products, projects, etc..


Functional and Technical Competencies

- Prepares, submits, and monitors applications of new products, changes in approved products, and KGMP.

- Ensures compliance with the Health Authority regulations and interpretations.

- Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management.

- Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters.

- Follows up of mandatory requirements for registration: local certificates, importation of samples, local testing, etc.

- Ensures Korean label contents and approves the final Korean label artwork.

- Researches and consolidates regulatory requirements and actively communicates with the manager.

- Provides functional and technical advice to junior levels and takes a core role on team projects.

- Actively participates in team, company, regional, global, cross-sector projects.

- Shares best practices and learnings with the team in terms of RA processes and templates, product registration, projects, etc.

- Leverages experience and learnings from the past to make reasonable decisions in the challenging situations.

- Participates in regulatory consultative meetings, task force teams, and projects to understand trend and issues of health authorities, other companies, and healthcare industry and to shape policies that are aligned with business objectives of the company.

- Understands business environment and business strategies and develops effective and results-oriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to meet milestones independently.

- Understands trends in the healthcare environment, changes in external marketplace, and competitors’ tendency and the influence of social, economic, and political factors on business and regulatory environment.

- Leverages a deep scientific and technical understanding of products (medical devices, biologics or pharmaceuticals).

-  Explains Regulatory impact of risks to cross-functional business partners to support informed risk taking.

- Applies knowledge of the sector, organizational goals, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and contribute to the development of business strategies.

- Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with business objectives. Takes accountability for the achievement of business goals and objectives.

Leadership Competencies

- Effectively manages multiple competing priorities of different functional partners based on factors such as required regulatory submission due dates, time constraints, urgency, and business need.

- Leverages an understanding of the organizational structure to effectively collaborate with stakeholders who have differing needs and viewpoints.

- Builds and leverages internal/ external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.

- Demonstrates active listening skills and develops written technical communications that are clear and tailored to the audience and business need.

- Engages with external stakeholders and demonstrates conviction, proactivity, and persistence especially when influencing others and overcoming resistance. Creates compelling positions in negotiations that build support and consensus with key stakeholders.

- Creates and delivers verbal and written communication with highlighting the most pertinent information for targeted stakeholders. Supports stakeholders to take actions if needed.

- Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset.

- Experiments and learns from trying new approaches and applying the new ideas from insights


- A minimum Bachelor’s degree

- Min. 5 years of experience in Regulatory Affairs, especially Medical Device(Cardiovascular space) preferred

- Deep understanding in regulatory requirements, laws, standards, and environment

- The incumbent must have the ability to work independently and process requests/work within required timeframes

- Experienced in handling diverse product registrations

- Excellent communication and interpersonal skills

- Experience in a multi-national or regional company is preferred

- Fluent in both verbal and written English and Korean

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