Remote Quality and Compliance Specialist for Medical Devices

3日前

Japan Jobgether
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Medical Device Quality Expert - REMOTE. In this role, you will play a crucial part in ensuring the highest standards for medical device quality and compliance. Your expertise will contribute to the adherence to regulatory standards and improvement of patient safety. You will collaborate with cross-functional teams to develop and implement strategies that align with industry regulations, ultimately facilitating the successful lifecycle of medical devices. Your leadership will help us to achieve compliance goals and enhance product quality, making a significant impact in the healthcare sector.

Accountabilities

  • Lead and oversee quality management system (QMS) activities for medical device products throughout the product lifecycle.
  • Develop and implement quality and compliance strategies to ensure adherence to regulatory requirements, standards, and guidelines (e.g., ISO 13485, FDA QSR, MDR).
  • Conduct risk assessments and mitigation activities to identify and address potential quality and compliance issues.
  • Provide guidance and support on regulatory submissions and interactions with regulatory agencies (e.g., FDA, notified bodies).
  • Lead and support internal and external audits, including supplier audits and regulatory inspections.
  • Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other teams to ensure quality and compliance objectives are met.
  • Stay abreast of emerging regulatory trends and changes affecting the medical device industry and proactively implement necessary updates to QMS processes and procedures.

Requirements

  • Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
  • Minimum of 8 years of experience in quality assurance and regulatory compliance within the medical device industry.
  • In-depth knowledge of relevant quality standards and regulations, including ISO 13485, FDA QSR, and EU MDR.
  • Experience leading quality management system implementations and maintaining compliance in a regulated environment.
  • Strong understanding of risk management principles and methodologies (e.g., ISO
  • Excellent communication and interpersonal skills, with the ability to effectively communicate complex regulatory requirements and concepts.
  • Proven ability to lead and influence cross-functional teams and drive quality and compliance initiatives to completion.
  • Quality and regulatory certifications (e.g., ASQ CQE, RAC) preferred but not required.

Benefits

  • Competitive compensation and benefits packages.
  • Opportunity to make a meaningful impact on patient health and safety.
  • Collaborative and inclusive work environment.
  • Access to professional development and training resources.
  • Work-life balance with flexible work options.
Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team We appreciate your interest and wish you the best Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

  • Remote Quality and Compliance Specialist for Medical Devices

    6時間前

    Japan Jobgether $100,000 - $120,000 per year

    We are currently looking for a Medical Device Quality Expert - REMOTE. · Lead and oversee quality management system (QMS) activities for medical device products throughout the product lifecycle. · ...

  • Remote Quality and Compliance Specialist for Medical Devices

    3日前

    Japan Jobgether

    This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Medical Device Quality Expert - REMOTE. In this role, you will play a crucial part in ensuring the highest standards for medical device quality and compliance. · Responsibilities · ...

  • Global Senior Logistics Analyst

    5日前

    Tokyo オリンパス株式会社

    オリンパスのサプライチェーン全体像を深く理解することができます。海外拠点や国際輸送サプライヤーとグローバル/クロスボーダーに連携し、様々な部門と協業しながら国際経験を積むことができます。 · ...

  • Legal & Compliance Manager

    13時間前

    Tokyo, Tokyo PERSOL CAREER BRS (Bilingual Recruitment Solutions)

    革新的な治療法を開発・提供する企業にて · Legal & Compliance Manager · 医療分野における革新的な治療法を開発・提供する企業の法務コンプライアンス部門の責任者として、状況を論理的に分析し、リスクと利益をバランス良く評価し、保守的な判断ではなく、会社全体のさまざまな機能と密接かつ積極的に連携してビジネスを支援します。 ...

  • Lead Regulatory Affairs Specialist

    1週間前

    Japan Jobgether

    +Job summaryThis position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Specialist - REMOTE. · ...

  • Japanese Language Specialist

    2週間前

    Japan Invisible Agency

    We are seeking Japanese language specialist candidates who have access to Android devices to support large-scale language model training. · With high-quality training data from you we need your expertise to help power the next generation of AI. · ...

  • Quality Assurance Manager

    5日前

    Tokyo Real

    + Quality Assurance Manager · Location: Tokyo or Nagoya (Hybrid / On-site) · About the Company: A rapidly growing AI×Biotechnology startup is developing next-generation diagnostics by combining advanced machine-learning technology with novel biomarker science. The company aims ...

  • Commercial Quality Specialist

    2週間前

    Tokyo LivaNova Full time

    As a global medtech company we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. · ...

  • Business Development Associate

    5日前

    Japan OPIS

    We are seeking a Business Development Associate who will help expand our global client network across the life sciences sector focusing on APAC region. · You'll collaborate with senior leaders to identify new business opportunities and connect with key decision-makers in pharma a ...

  • Regulatory Affairs Senior Specialist

    2週間前

    Tokyo CooperVision

    The Regulatory Affairs Senior Specialist shall contribute and lead the Regulatory Affairs for the CooperVision Japan business. · ...

  • Medical Education Manager, Japan

    4週間前

    Chiyoda Cook Medical ￥5,000,000 - ￥10,000,000 per year

    + Develop innovative medical education training programs for healthcare professionals. + Lead teams to establish internal processes to support and deliver medical education training programs. + Collaborate with divisional stakeholders to develop content and messaging that meets c ...

  • Remote Senior Engineering Specialist

    2週間前

    Japan Jobgether

    This position is posted by Jobgether on behalf of a partner company seeking a Construction Program Design Specialist - REMOTE to steer large-scale engineering initiatives with implications for U.S. interests abroad. · Lead risk management and engineering assessments for complex c ...

  • Clinical Specialist

    2週間前

    Tokyo Barrington James $100,000 - $150,000 per year

    This organization is dedicated to advancing patient care through innovative, technology-driven surgical solutions.With a strong focus on improving clinical outcomes and quality of life, the company supports healthcare professionals by delivering effective treatment options. · ...

  • Medical Education Manager, Japan

    2週間前

    Chiyoda Cook Group Full time

    Develop innovative medical education training programs for healthcare professionals including fellows and residents as applicable for assigned specialties in assigned geography. · ...

  • Alexion Japan】Senior Quality Auditor, Alexion Operations Audit

    6日前

    Tokyo Alexion Pharmaceuticals, Inc.

    The Senior Quality Auditor at Alexion Rare Disease Unit (ARDU) has key responsibilities for auditing a variety of GMP/GDP sites (internal and external suppliers) used for commercial and development projects. · ...

  • Regulatory Affairs Expert

    7日前

    Japan Merck

    +Work with Regulatory Experts to perform tasks such as DMF preparation and submission. · +Preparation, submission, and maintenance of DMF for APIs and excipients · Acting as an agent for Foreign Manufacturer Accreditation · Maintenance of regulatory approvals for In Vitro Diagnos ...

  • Sr. Associate Consultant/Consultant

    2週間前

    Japan Red Nucleus

    · Red Nucleus is the premier provider of strategic learning, performance, and process solutions exclusively for the life sciences industry. · At least 5 years (Sr. Associate), 8-10 years (Consultant) of experience in the pharmaceutical industry with a focus in Regulatory Operati ...

  • Clinical Trial Psych Rater

    1日前

    Tokyo IQVIA Part time

    Review scales administered by raters to confirm standardized assessment practices. · ...

  • Sr Mgr(MD&PhD), Lung Cancer MAS Team Lead :4949017

    2日前

    Japan ファイザー

    The Sr Mgr(MD&PhD), Lung Cancer MAS Team Lead will lead a team of MAS and shape the local strategy to ensure delivery of scientific-medical expertise. · ...

  • Clinical Affairs Specialist

    3週間前

    Tokyo Abbott Laboratories Full time

    This role is responsible for managing study documentation and operational progress using Clinical Trial Management System, · Ensure compliance with clinical protocol and applicable regulatory requirements such as GCP, ISO14155 or GPSP through appropriate management, review, and m ...

  • Product Marketing Manager

    2週間前

    Tokyo Real $100,000 - $120,000 per year

    We are looking for an experienced Product Marketing Manager to support the commercialization and adoption of advanced robotic-assisted surgical technologies. · ...