[Remote] Integration Sr. Project Manager

Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is a medical device company seeking a contractor for product life cycle support of a Class III medical device during a medical leave. The role involves providing strategic regulatory guidance, supporting integration activities, and ensuring compliance with regulations.

Responsibilities

• Provide strategic regulatory guidance and support integration activities related to a newly acquired entity
• Represent the Regulatory Affairs function during integration and implementation activities
• Help define and draft procedures as needed, including claims review and approval
• Author internal regulatory documentation in accordance with established requirements and procedures
• Assess product and process changes and complete regulatory impact assessments
• Support PMA, MDR, and MDD file maintenance for high risk products
• Ensure compliance with internal procedures and applicable regulations
• Support internal processes to maintain compliance with agency approvals
• Collaborate with international personnel and external consultants to deliver against the project plan
• Support international registrations and renewals as needed

Skills

• Provide strategic regulatory guidance and support integration activities related to a newly acquired entity
• Represent the Regulatory Affairs function during integration and implementation activities
• Help define and draft procedures as needed, including claims review and approval
• Author internal regulatory documentation in accordance with established requirements and procedures
• Assess product and process changes and complete regulatory impact assessments
• Support PMA, MDR, and MDD file maintenance for high risk products
• Ensure compliance with internal procedures and applicable regulations
• Support internal processes to maintain compliance with agency approvals
• Collaborate with international personnel and external consultants to deliver against the project plan
• Support international registrations and renewals as needed

Company Overview

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. It was founded in undefined, and is headquartered in South Plainfield, New Jersey, USA, with a workforce of 51-200 employees. Its website is http://katalysthls.com.

Company H1B Sponsorship

Katalyst CRO has a track record of offering H1B sponsorships, with 3 in 2026, 37 in 2025, 14 in 2024, 24 in 2023, 52 in 2022, 54 in 2021, 39 in 2020. Please note that this does not guarantee sponsorship for this specific role.