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Director Regulatory, APAC - Singapore

싱가포르 요청 번호1018
2023년 6월 9일 금요일

Cynosure 의료 미학 산업을 선도하고 변화시킬  있는 경쟁력있는 위치에 있습니다.  우리는 이것이 환자의 삶과 의사들의 삶을 향상시키는 목적 지향적인 사업이라는 믿음을 가지고 있습니다.

  • 우리는 소비자가 의료 미학에 참여하도록 고무하는 첨단 마케팅으로 건전하고 발전하는 의료 미학 산업을 주도하는  열정을 쏟고 있습니다.
  • 우리는 과학 기반 기술의 선두주자로 되어 소비자들을 위한 치료 수준을 향상시킵니다.
  • 우리는 모두가 인정하는 혁신의 리더가 되는  끊임없이 집중하며 모든 사람들 속에서 증가하는 소비자 치료의 수요를 충족시키고 있습니다.
  • 우리는 5대륙의 15 국가들에 정규 직원들과 130 이상의 국가들에 서비스를 제공하는 유통 업체를 두고 있으며 타의 추종을 불허하는 글로벌 입지를 구축하고 강화하기 위해 최선을 다하고 있습니다.
  • 우리는 직원들을 가장 중시하며 개인의 발전이 비즈니스 발전을 추동한다고 믿습니다.
  • 우리는 고객을 사랑하고최첨단 기술서비스마케팅 지원임상 교육을 제공하여 환자의 치료를 개선하고 그들의 삶을 개선하기 위해 노력하고 있습니다.

Cynosure에서 우리는 영향력을 미치고 모든 사람들이 앞장서서 가치를 창조하고 더하도록 고무하는 사람들을 찾습니다결과적으로 팀에 투자하여 사람들의 경력을 발전시키고높은 성과를 내는 문화 지향적인 조직을 구축합니다우리는 하나의 팀으로 일하여 함께 성공을 이룩합니다.

 

우리가 글로벌 팀으로 성장하는  따라 지금이 우리와 함께 가장 좋은 시간입니다. Cynnosure 의료 미학 시장의 선두 주자로서 25 동안 피부과 의사성형외과 의사의료 스파의료 실무자들을 위한 제품을 개발제조마케팅해 왔습니다우리는 미학 업계에서 가장 포괄적인 제품 포트폴리오를 갖추고 피부 재생신체윤곽성형제모여성 건강을 비롯한 여러 범주의 제품을 제공합니다.  

 

우리의 임무는 미래의 미학 업계의 리더를 형성하고 우리의 기술을 사용하는 모든 사람들이 자기의 아름다움을 발견하도록 도우면서 Cynosure 고객들이 성공하도록 하는 것입니다.

우리에 대해 자세히 알아보시려면 LinkedIn  Instagram 사이트를 팔로우하고 www.Cynosure.com 방문해주십시오

Role Purpose

The Regulatory Director will be anticipating and shaping the environment across APAC & ANZ, enabling Cynosure to lead through innovation.

Role is responsible to lead and/or participate in cross functional and cross company interdisciplinary teams responsible for defining and implementing regulatory strategy in APAC and ANZ. Manage regulatory interactions with distributors, consultants or partners to achieve regulatory objectives in line with individual development and corporate goals. Primary contact with regulatory authorities in Asia & ANZ.

Role Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Leadership:

  • Lead/participate in cross functional and cross company interdisciplinary teams establishing international regulatory strategy for commercial products.
  • Play a thought and people leadership role within the Global RA community
  • Build strong teams with peers and local market experts based on functional expertise and mature leadership personality
  • Represent RA in the Leadership Team, creating transparency through proactive collaboration within the matrix

Strategy:

  • Establish Cynosure as a shaping influence in the regulatory environment across key markets
  • Create APC/ANZ RA strategy and ensure it dove-tails and complements the Global Strategy
  • Shorten lag times between innovation and ability to implement in global key markets
    • Deep dive into key Asian markets and establish root cause issues for lag times
    • White paper of fast changing regulatory environment
  • Scan changing ongoing regulatory environment and proactively incorporate changes into strategy as well ensure business readiness
  • Within the approved strategy set clear priorities and achieve alignment with key stakeholders

Operations:

  • Manage and resolve the tension between global excellence and new innovation with local execution challenges
  • Drive Efficiency
    • Drive regulatory approvals by providing clear project priorities.
    • Improve internal systems/processes to ensure ability to be proactive in approach (eg planning)

  • Drive Effectiveness
    • Support post-market surveillance efforts monitoring the performance of Cynosure devices.
    • Ensure competent execution of agreed priorities through working with all relevant stakeholders and guard against distraction/ competing enterprise asks
    • Ensure all APAC/ANZ marketing material is in line with local regulatory requirements.

  • Leverage regular Influencing Conversations to build Cynosure’s shaping influence
    • Maintain communication with Regulatory Bodies as necessary.
    • Manage regulatory interactions with distributors, consultants or partners.
  • Monitor and ensure both compliance with and documentation of compliance with Cynosure’s policies and procedures as outlined in various Company policies, including the Global Approval Authority Matrix and other mandatory policies pursuant to one’s job description.

Education & Experience

  • BA/BS required. Master’s degree preferred
  • 15+ years’ experience in a medically regulated and technical environment with at least 5+ years in a medical device company.
  • Knowledgeable of medical device regulation in Asia, Europe and Latin America.
  • Min 5 years of people leadership in a matrixed and geographically environment
  • Technical/Functional Experience:
    • Experience with successful preparation and submission of applications in APAC & ANZ regions, including (but not limited to) countries such as China, Japan, Taiwan, Korea, and Australia.
    • Experience with aesthetic medical devices. Experience with aesthetic lasers is a plus.
    • Experience in supporting international registrations
    • Excellent knowledge of ISO13485.
    • Strong understanding of marketing and promotional requirements in Europe and Asia.
    • Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle
    • Experience with ISO 14155 and other clinical regulatory requirements is a plus

Competencies

  • Strong attention to detail and well-developed analytical thinking skills
  • Strong project organization and time management skills, including the ability to prioritize multiple challenging project timelines while ensuring all deadlines are met
  • Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objective
  • High level of spoken and written English
  • Strong influencing and negotiating skills with very senior internal and external stakeholders
  • Excellent communication skills; written and verbal
  • Learning Agility, with emphasis on Mental agility and Change agility
  • Strong conceptual thinking
  • Strong problem-solving skills
  • Passion for results
  • Strong matrix influencing skills
  • Building organizational talent
  • Proven ability to balance autonomy and collaboration

Personal Attributes

  • Is resilient
  • High level of integrity
  • Accurate self-insight
  • High learning orientation
  • Calm under pressure
Cynosure는 모든 채용 과정에 포용성과 다양성을 목표로 하여 동등한 기회를 제공합니다.  

기타 세부 정보

  • 직무군 Regulatory
  • 직무 기능 General Regulatory Affairs
  • 급여 유형 임금
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