[Medical Devices] Regulatory Affairs Manager
Johnson & Johnson
Taipei, TW
9天前

OVERALLRESPONSIBILITIES :

Responsible for creating and executing the strategy for obtaining product registrations and supporting the lifecycle management of Medical Device products across designated Portfolio(s) in (Region) Wave 3 countries.

POSITION DUTIES & RESPONSIBILITIES :

  • Present a single voice for designated portfolio in (Region) Wave 3 countries to Regional Key Stakeholders (Commercial leadership, Supply Chain, Quality, Medical Safety and Health Economics), with the aim of :
  • Facilitating a more thorough understanding of local country regulatory requirements
  • Providing outstanding support to our the local country Regulatory Affairs teams;
  • Defining best launch strategies to accelerate speed-to-market
  • Serving as the Regulatory project lead for complex variations, new product introductions, acquisitions and divestments impacting the designated portfolio in (Region) Wave 3 countries, specifically those requiring alignment with Supply Chain, Quality and Marketing strategies.
  • On behalf of the countries in (Region) Wave 3 countries, responding to all requests for change impact assessments originating from the Business Units for the designated portfolio(s), seeking input from local Regulatory teams as needed, and ensuring all stakeholders (including Local Regulatory teams) are notified of the changes
  • Interacts with Dossier Excellence Centers and RALI Business Unit teams to obtain timely documentation for registration, and thereafter, manage / review dossier content to ensure compliance with regulatory strategy and local regulations.
  • Monitor and report submission and approval timelines against defined RALI metrics and utilize business Insight to improve performance.
  • Work with RALI colleagues to develop and implement streamlined, consistent processes for both new products and life cycle management through best-
  • practice sharing and continuous improvement, to reduce risk and drive regulatory compliance across Wave 3 countries

  • Participate in developing and executing exciting programs to strengthen talent development and pipeline across RALI and Wave 3 countries.
  • Functional and Technical Competencies :

  • Solid knowledge of regulatory requirements in (Region) Wave 3 markets and the ability to articulate country requirements to multiple audiences and to translate regulations into clear data requirements to support registrations
  • Highly skilled in establishing partnerships with regional colleagues, successfully influence functional leaders of all levels and able to work collaboratively in a highly matrix environment
  • Demonstrated strong leadership, organizational, and planning skills with the ability to work cross-functionally with a diverse work force and customer base.
  • A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously
  • Strong analytical and process improvement skills
  • Must be able to communicate clearly, succinctly and effectively over the phone and in writing in English.
  • Leadership Competencies :

  • CONNECT by cultivating strong internal partnerships and collaborations through transparent and constructive conversations, contributing to high-
  • performing teams within RALI and across business functions

  • SHAPE by translating country-specific and / or regional insights into innovative and viable solutions, adding value to RALI and the business.
  • LEAD by driving a thorough understanding of local regulatory requirements in Wave 3 countries relevant to the designated portfolio(s) across regional key stakeholders, and RALI organization
  • DELIVER a robust and well communicated regulatory strategy for designated portfolios across Wave 3 countries thus positioning the business to achieve both short-
  • term and long-term results.

    Leadership Competencies :

  • CONNECT by cultivating strong internal partnerships and collaborations through transparent and constructive conversations, contributing to high-
  • performing teams within RALI and across business functions

  • SHAPE by translating country-specific and / or regional insights into innovative and viable solutions, adding value to RALI and the business.
  • LEAD by driving a thorough understanding of local regulatory requirements in Wave 3 countries relevant to the designated portfolio(s) across regional key stakeholders, and RALI organization
  • DELIVER a robust and well communicated regulatory strategy for designated portfolios across Wave 3 countries thus positioning the business to achieve both short-
  • term and long-term results.

    Minimum of 5 years of medical device, diagnostic or related industry experience.

  • Experience shall include relationship building, negotiation, management and a proven track record of strategic thinking.
  • Also needed, is an in depth knowledge and hands on experience obtaining regulatory approval for a wide range of Medical devices.

    Experience in Pharmaceutical and Biologic products desirable.

  • Demonstrated expertise and knowledge and understanding of applicable Regional (ASPAC / EMEA / LA), US and international medical device regulations.
  • Demonstrated ability to set effective business, technical and / or regulatory direction.
  • Demonstrated experience of managing multiple franchise projects simultaneously and consisting of varying degrees of complexity.
  • Masters degree or equivalent required.
  • Advanced computer skills
  • Excellent English skills and Bi-lingual preferred.
  • Please note that there is no relocation assistance provision for this position. The selected candidate can continue to be based in his or her home country.

    see above

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