Logo for Katalyst CRO

Integration Sr. Project Manager

Katalyst CRO

Role overview

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.

Key facts

Hard skills

FDA Regulations Process Integration Government Regulation Analysis Project Management Registration Authority

Other skills

  • Collaboration
  • Communication
  • Teamwork

About the company

Katalyst CRO logo

Katalyst CRO

Contract Research Organizations (CRO)

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. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

Job Description:
A medical device company in Texas is seeking a contractor to provide product life cycle support for a Class III medical device while covering a medical leave. The ideal candidate will be based in Texas, but we will also consider qualified candidates outside the area if they are a strong fit and within budget.

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.

Apply once. Then go straight to the hiring manager.

After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
Unlocked after you apply
·

Project Manager Related jobs

New Jersey (USA)Project Manager

Other jobs at Katalyst CRO

Premium

Reach out to the hiring manager directly.

Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

  • Full match report with fit score and gaps
  • Career diagnostics on how recruiters read you
  • Curated company matches and warm intros
  • 48h early access to new roles

Cancel anytime.