Qa Ra Specialist

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: Quality and Regulatory Affairs Engineer – Medical Devices
Company: Katalyst Healthcares & Life Sciences
Location: Remote
Contract Type: Contract

Company Overview:

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions in clinical research for drugs, biologics, and medical devices. We have immediate job opportunities in Drug Safety, Pharmacovigilance, and Clinical Research. We work with leading university hospitals, pharmaceutical companies, and recruiting partners to advance clinical trials and development.

Job Description:

We are seeking an experienced Quality and Regulatory Affairs Engineer with expertise in the Medical Product Development Process, specifically for Electromechanical Devices. The role involves managing regulatory compliance and quality assurance throughout the development lifecycle, ensuring adherence to medical process standards and regulatory requirements.

Responsibilities:

Compile Design History Files (DHF) and Technical Files.
Manage regulatory assignments with a strong understanding of medical process standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
Ensure thorough understanding and application of US FDA regulations and EUMDD regulations.
Maintain Quality Assurance in accordance with defined processes.
Oversee the Engineering Change Management Process.
Update and maintain Risk Management Files.
Participate in Design Review Meetings to assess product design compliance.
Prepare Regulatory Strategy documents for electromechanical devices.
Conduct Regulatory Assessments of electromechanical devices.
Review and ensure the regulatory compliance of Technical Documents.
Prepare Regulatory Submissions for multiple international markets.
Ensure regulatory documentation aligns with global standards.

Minimum Qualifications:

Minimum 5 years of experience in Quality Assurance within the Medical Device industry.

Additional Information:

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

Apply Now: Katalyst Healthcares Careers

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Qa Ra Specialist

Job Description

Company Overview:

Job Description:

Responsibilities:

Minimum Qualifications:

Additional Information:

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