Posted to MedZilla on 8/23/2019

Takeda Pharmaceuticals

US-MA, Associate Director - Device Quality Regulatory Surveillance and Compliance SR0037289-MZ


Primary Role

  • Oversees compliance for Medical Devices and Combination products to all applicable regulations including but not limited to: 21 CFR 4, 820, 803, GHTF, ISO13485 & 14971, MDD/MDR, IVDD/IVDR, MDSAP, etc
  • Establishes and maintains site and product certifications and provides global inspection leadership and submission support
  • Establishes and/or improves cGMP processes for Device and Combination Products (DCP) quality management system (QMS)
  • Establishes and maintains support for global product surveillance for medical devices, diagnostics, software devices, and combination products
  • Interfaces with and provides guidance on matters pertaining to Device Quality Assurance to cross functional stakeholders in the Device Center of Excellence and to other Quality organizations
  • Assesses product quality performance to demonstrate levels of control, capability, and compliance.


40% Ensures functionality and maintenance of the certified DCP QMS in compliance with applicable regulations and standards. Ensures that all processes needed for the QMS are maintained and inspection readiness is maintained. Device specific processes include but are not limited to:

  • Device Master Records
  • Customer Feedback
  • Technical Files / Dossiers
  • Establishment and Product Registration / Certification
  • Post-Market Surveillance and Risk Management
  • Regulatory Intelligence
  • Device Vigilance
  • Medical Device Labeling

30% Enables support for other global quality systems processes including but not limited to:

  • Management Review
  • Customer Complaints
  • CAPA
  • Deviations
  • Change control
  • Quality Improvement Plans
  • Trending and KPI Monitoring
  • Training

20% Participates in ongoing Quality initiatives, Integration support and Operational Excellence

10% Influences QMS strategy to enhance and execute sustainable Device Quality support for internal and external manufacturing, packaging, testing and release of device and combination products

Education & Experience Requirements


  • Bachelor s Degree in Engineering, Natural Science and/or Medical Degree or equivalent technical discipline required
  • At least 10 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 5 years in Quality Assurance/Engineering
  • Knowledge of international regulations for Device and Combination Products particularly Medical Device Directive 93/42/EEC, US 21 CFR Part 4, 820, 803, ISO 13485 and ISO 14971, MDD/IVD, MDSAP, and MDR/IVDR
  • Experience with Class I & II & III sterile and non-sterile medical devices and implantable devices
  • Experience interacting and collaborating with cross-functional global teams
  • Experience working with external manufacturing partners
  • Strong operations background to ensure value added and effective quality operations


  • Advanced Degree;
  • Experience working in a post-market quality support function preferred
  • Knowledge of in-vitro diagnostics
  • Experience assessing root cause analysis and effective investigation practices
  • Extensive experience in trend analysis and statistical techniques
  • Understanding of GDPs and global supply and distribution networks

Other Requirements

Domestic and international travel up to 25% for business meetings with local staff, corporate peers/collaborators, Device Supplier Audits, Contract Manufacturing Operators and to stay current with professional development opportunities.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law -

EEO is the Law Supplement -

Pay Transparency Policy -

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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