Johnson & Johnson
Regulatory Affairs Specialist
Regulatory Affairs Specialist
9 month contract
The Regulatory Affairs Specialist is responsible for contributing to the Regulatory Affairs International team in providing regulatory advice and developing regulatory strategies to support project teams as the regulatory representative on multidisciplinary teams.
Responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy line of Joint Reconstruction products in the primary ASPAC markets of China, Japan, Australia/New Zealand.
This includes the preparation of regulatory documentation (e.g., Dossiers and Technical Documentation) for submission to regulatory Health Authorities or internal regulatory assessment documentation.
The Regulatory Specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes Joint Reconstruction products for compliance to global regulations and company policies and procedures.
- Prepare and/or assist in the preparation of international market applications to support registrations in conjunction with the cross-functional team
- Assures that all submission documentation, record keeping, and reporting meet regulatory requirements.
- Responsible for or assisting in interacting with regulatory authorities as necessary, including preparing responses to health authorities for submitted applications/submissions
- Support the interpretation of regulatory requirements and determine strategies to obtain timely approvals
- Review product labeling and product support information for currently marketed products to ensure that product information is consistent with approvals and in compliance with relevant regulations and guidance.
- Providing regulatory support for currently marketed products, including the review and approval of engineering drawings, labeling, technical files, and engineering change orders.
- Incumbent knows, understands, incorporates and complies with 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.
- 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, MDR, etc.).
- Perform other duties as assigned.
- Minimum 1 years of prior regulatory experience in medical devices or similar regulated industry
- Demonstrated aptitude for preparing and submitting government submissions are preferred.
- Experience working with cross-functional teams is preferred
- Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR and presiding guidance’s and standards
- Knowledge and/or Familiarity of China NMPA, Japan PMDA, and Australia TGA Regulations, presiding guidance’s and standards is a plus
- Prior interaction with the regulatory agencies is a plus
- Knowledge of orthopedic implants a plus
- Excellent written and oral communication skills
- Ability to handle multiple tasks and be detail-oriented