6 дней назад
Senior Analyst, Standards Specialist (MedTech)
94 000 - 151 800$
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.
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