Назад
Company hidden
6 дней назад

Senior Analyst, Standards Specialist (MedTech)

94 000 - 151 800$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Senior Analyst, Standards Specialist (Quality/Regulatory): Coordinating enterprise quality standards revisions, controlled-document approvals, metrics, and standards access across a regulated MedTech organization with an accent on traceability, compliance, and stakeholder coordination. Focus on managing review workflows, analyzing cycle-time and backlog trends, and applying approved AI tools to improve standards-program efficiency.

Location: New Brunswick, New Jersey, United States of America; additional job posting locations include Georgia, Horsham and Raritan in the United States, and Toronto, Canada.

Base pay: $94,000–$151,800 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions through its MedTech and Innovative Medicine businesses.

What you will do

  • Coordinate end-to-end revisions of enterprise quality standards, including change-request intake, tracking, assessment review, and governance packages.
  • Partner with sector subject matter experts and standards owners to facilitate content updates and revision cycles.
  • Route controlled documents through document management systems for review, approval, and publication.
  • Maintain review calendars, program metrics, dashboards, and trend analysis covering cycle time, backlog, revisions, and on-time completion.
  • Document regulatory and guidance drivers for standards updates and maintain traceability across internal tools and references.
  • Support environmental scans, standards website updates, continuous improvement projects, and approved AI-enabled workflow improvements.

Requirements

  • Bachelor’s degree in life sciences, quality, regulatory affairs, engineering, or a related field.
  • At least five years of quality experience in a regulated industry; pharmaceutical or medical device experience is preferred.
  • Knowledge of quality system documentation, standards, policies, SOPs, and GxP or medical device requirements.
  • Experience with controlled-document authoring, revision and approval workflows, document management systems such as Veeva, and collaboration tools such as SharePoint.
  • Proficiency in Excel, data visualization, process automation, metrics analysis, and technical writing.
  • Strong facilitation, stakeholder coordination, communication, attention to detail, data integrity, and deadline-management skills.

Nice to have

  • Experience in pharmaceutical or medical device environments.
  • Knowledge of ISO 9001, quality management systems, regulatory affairs, and process improvement.

Culture & Benefits

  • Inclusive work environment guided by the company’s Credo and focused on employee dignity and merit.
  • Participation in pension and 401(k) savings plans.
  • Eligibility for the long-term incentive program.
  • Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →