RA Special Projects

Job Title: RA Specialist 4 - Regulatory Compliance

Project Goal: Ensure regulatory guidance and submissions are executed for RA Special Projects

Project Duration: 12 Months with possible extension

Services Location: Services will be performed at remote location or at Buyer’s facility with an address at 325 Paramount Dr, Raynham MA 02767, United States or at Supplier locations and other project related locations

Salary: $ 100 -115/hr. on W2 (All Inclusive)

Work Schedule: Mon-Fri 40 hrs. work week

Job Type: W2, Temporary

Job Details:

·       Services/Deliverables Frequency (one time, daily, weekly, monthly, quarterly) Due Date Acceptance Criteria (specific for the Service/Deliverable)

·       Service provider shall complete all training by the organization to perform the duties of a regulatory professional within the J&J Quality System Daily Due date defined by project schedule. All required training completed. Obtain access to needed J&J databases.

·       Service provider shall provide the regulatory strategy for the Special Project activities In accordance with the project schedule 2021-2022 in accordance with Project schedule As reviewed and approved by J&J Stakeholder Service provider shall ensure compliance with all applicable regulatory requirements and J&J policies Daily Daily 2021-2022 in accordance with Project Schedule. N/A

·       Service provider shall prepare internal documentation, Technical File updates, EU Design Dossiers, PMA Supplements, and Internal registration support according to the project schedules. In accordance with the project schedule 2021-2022 in accordance with Project Schedule. As reviewed and approved by J&J Stakeholder

·       Generation of Regulatory Plan documentation as required by the project. Interaction with global stakeholders and cross-functional teams in Daily 2021-2022 in accordance with Project Schedule. As reviewed and approved by J&J Stakeholder Page 4 of 4 identification of regulatory impact

           • Change Orders

           • Technical File Updates

           • EU Design Dossiers PMA

           • Supplements International Registration Support Project Support

           • Support regulatory strategy

           • Attend project meetings with crossfunctional teams

           • Review product labeling in accordance with internal J&J process and procedures