Senior Regulatory Affairs Lead – MedTech Devices

Johnson & Johnson MedTech; Raynham (MA); Vor Ort; USD 79.000 - 128.000; Vollzeit

Benefits dieser Stelle

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Zusammenfassung

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Specialist to support regulatory activities for DePuy Joint Reconstruction products. This role involves preparing regulatory documentation for IDE, 510(k), PMA, and Technical Documentation, as well as facilitating global registrations and ensuring compliance with FDA and MDR standards.

The position requires a BA/BS degree, familiarity with regulatory frameworks, and strong communication skills.

Qualifikationen

• BA/BS Degree required; advanced degree or equivalent work experience preferred.
• Knowledge of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance and standards a plus.
• Familiarity with orthopedic implants a plus.
• Excellent written and oral communication skills.
• Ability to handle multiple tasks, self-motivate and be detail oriented.

Aufgaben

• Prepares regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements.
• Provides support in preparation, writing and submission of global registration activities (Japan, China, Australia, NZ) requirements.
• Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact.
• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, etc.).
• Perform other duties as assigned.

Kenntnisse

Communication skills

Multitasking

Detail oriented

Ausbildung

BA/BS Degree

Jobbeschreibung

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Specialist to support regulatory activities for DePuy Joint Reconstruction products. This role involves preparing regulatory documentation for IDE, 510(k), PMA, and Technical Documentation, as well as facilitating global registrations and ensuring compliance with FDA and MDR standards.

The position requires a BA/BS degree, familiarity with regulatory frameworks, and strong communication skills.