22 часа назад
Manager, Integration, Deployment Systems & Development (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Integration, Deployment Systems & Development (Regulatory Systems): Leading the integration, deployment, and development of regulatory systems and tools for compliant medical-device operations with an accent on data integrity, regulatory requirements, and cross-functional implementation. Focus on translating business and regulatory needs into scalable system solutions, managing change, supporting audits, and driving continuous improvement.
Location: Hybrid role available in Raynham, Massachusetts; West Chester, Pennsylvania; Warsaw, Indiana; Palm Beach Gardens, Florida; New Jersey; or Zuchwil, Switzerland. Limited occasional domestic or international travel may be required.
Company
Johnson & Johnson MedTech develops healthcare and medical-device solutions, with the role supporting the planned standalone DePuy Synthes orthopaedics business.
What you will do
- Lead regulatory system integration, deployment, and development initiatives aligned with compliance requirements.
- Partner with Regulatory Affairs, Quality, IT, and business stakeholders to define requirements and implement compliant solutions.
- Support deployment, maintenance, and enhancement of regulatory systems and tools while protecting data integrity and usability.
- Manage change activities related to system updates, integrations, and enhancements.
- Support audits, inspections, and assessments involving regulatory systems and data.
- Assess regulatory and system changes and drive improvements in efficiency, scalability, and compliance.
Requirements
- Bachelor’s degree in Regulatory Affairs, Information Systems, Engineering, Life Sciences, or a related discipline.
- English is required.
- Typically 6–8 years of progressive experience in regulatory systems, regulatory operations, IT systems integration, or a related role within a regulated industry.
- Experience supporting system integration, deployment, or development in a compliance-driven environment.
- Strong understanding of regulatory processes and data requirements, with the ability to translate them into system solutions.
- Strong project management, problem-solving, communication, and stakeholder management skills.
Nice to have
- Experience in medical devices, healthcare, or another highly regulated industry.
- Familiarity with regulatory information management systems or related platforms.
- Experience supporting audits or inspections involving regulatory systems.
- Experience in a global or matrixed organization and with system or process improvement initiatives.
- Regulatory Affairs Certification or relevant systems/project certifications.
Culture & Benefits
- Inclusive work environment focused on employee dignity, diversity, and individual contribution.
- Opportunity to support healthcare innovation and the planned DePuy Synthes orthopaedics organization.
- Employment is expected to transition to DePuy Synthes after the planned business separation, subject to legal, regulatory, and consultation requirements.
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