Regulatory Affairs Specialist, Medical Device

2+ years

Not Disclosed

Baltimore

10 Nov. 21, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Specialist - Medical Devices
Company: Katalyst Healthcares & Life Sciences
Location: Remote
Contract Type: Contract

Company Overview:

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for contract research positions in clinical trials across drugs, biologics, and medical devices. We have several immediate job opportunities available in Drug Safety, Pharmacovigilance, and Clinical Research. We collaborate with leading university hospitals, pharmaceutical companies, and recruiting partners to drive the success of our clinical programs.

Job Description:

We are looking for a Regulatory Affairs Specialist with experience in medical devices. The role involves working with regulatory assignments, ensuring compliance with standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 62366. Candidates should be proficient in US FDA and EUMDD regulations, managing the engineering change process, and preparing regulatory submissions for electro-mechanical devices.

Requirements & Responsibilities:

Compile Design History Files (DHF) and Technical Files.
Handle regulatory assignments with a strong understanding of medical process standards like ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
Apply US FDA and EUMDD regulations in the regulatory process.
Ensure Quality Assurance as per the defined processes.
Manage Engineering Change Management process.
Update Risk Management Files as required.
Participate in Design Review Meetings and provide regulatory insight.
Prepare Regulatory Strategy documents for medical devices.
Perform Regulatory Assessments for electro-mechanical devices.
Review Technical Documents for regulatory compliance.
Prepare Regulatory Submissions for multiple countries.

Additional Information:

All your information will be kept confidential according to EEO guidelines.

Apply Now: Katalyst Healthcares Careers

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Regulatory Affairs Specialist, Medical Device

Job Description

Company Overview:

Job Description:

Requirements & Responsibilities:

Additional Information:

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