Logo for Katalyst CRO

Regulatory Affairs Specialist

Katalyst CRO

Role overview

Qualifications

  • Experience with medical devices / healthcare regulatory affairs
  • Knowledge of U.S. and OUS device regulations, especially EU regulations
  • Experience developing or supporting Regulatory Affairs strategies
  • Experience working with cross-functional teams

Responsibilities

  • Support execution of regulatory project plans
  • Compile and prepare global regulatory submissions
  • Review technical and scientific data supporting submissions
  • Prepare responses to questions from regulatory authorities

Key facts

Hard skills

Other skills

  • Communication
  • Editing

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

Role Summary:
Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations.
Key Responsibilities:
  • Support execution of regulatory project plans.
  • Compile and prepare global regulatory submissions.
  • Review technical and scientific data supporting submissions.
  • Prepare responses to questions from regulatory authorities.
  • Maintain regulatory files and documentation.
  • Assist with labeling, SOPs, and departmental documents.
  • Track regulatory submission/documentation status.
  • Edit and proofread regulatory documents.
  • Participate in cross-functional project teams.
  • Manage multiple regulatory projects and priorities.

Must-Haves:

  • Experience with medical devices / healthcare regulatory affairs.
  • Knowledge of U.S. and OUS device regulations, especially EU regulations.
  • Experience developing or supporting Regulatory Affairs strategies.
  • Experience working with cross-functional teams.
  • Experience interacting with external regulatory authorities, such as FDA and TÜV.
  • Bachelor's degree in a relevant scientific discipline or equivalent experience.

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
·

Regulatory Affairs Specialist Related jobs

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.