21 час назад
Director, Enterprise Regulatory Compliance (MedTech)
150 000 - 258 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Enterprise Regulatory Compliance (MedTech): Providing enterprise oversight of cGMP regulatory compliance across pharmaceutical and medical device businesses with an accent on risk assessment, inspection readiness, audit classification, and executive reporting. Focus on interpreting regulations, managing escalations and recalls, analyzing compliance data, and applying approved AI-enabled tools to improve compliance reviews.
Location: New Brunswick, New Jersey, United States; the role is also available in Athens and Cornelia, Georgia; Horsham, New Brunswick, Raritan, and Titusville, New Jersey; and Washington, DC. Hybrid work and up to 20% domestic and international travel may be required.
Base pay: $150,000–$258,750 per year.
Company
Johnson & Johnson MedTech develops healthcare solutions across medical devices and pharmaceuticals.
What you will do
- Serve as the enterprise subject-matter leader and single point of contact for cGMP regulatory compliance, policy interpretation, issue triage, and decision support.
- Assess manufacturing, quality, and compliance risks and support consistent application of global regulations, standards, and policies.
- Review and classify Health Authority inspections, corporate cGMP audits, FDA responses, recalls, and other compliance issues.
- Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
- Analyze regulatory compliance data, lead data-driven reviews, and deliver actionable insights to senior leadership.
- Lead compliance escalation governance, provide cGMP training, and support audits, due diligence, acquisitions, health authority responses, and field action decisions.
Requirements
- Bachelor’s degree and at least 10 years of relevant quality and compliance experience.
- Required experience in cGMP regulatory compliance for medical devices and/or pharmaceuticals.
- Demonstrated leadership in cGMP compliance and strong written and oral communication skills.
- Ability to influence across cultures, functions, and organizational levels without direct line authority.
- Self-direction and the ability to work effectively in a complex, matrixed environment.
- Willingness to travel domestically and internationally up to 20% as business needs require.
Nice to have
- Advanced degree or relevant certification.
- Experience working for a Health Authority or Notified Body.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo and focused on diversity and dignity.
- Participation in pension, 401(k), savings, and long-term incentive programs, subject to plan terms.
- Vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.
- Support for inclusive interview accommodations for applicants with disabilities.
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