SENIOR REGULATORY SPECIALIST

BioPhase; San Diego (CA); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions for medical devices. This remote, temporary position requires extensive experience in the IVD industry and strong project management skills. The successful candidate will ensure compliance with FDA and CE regulations, prepare technical documentation, and support OEM customers in obtaining necessary certifications. Join a dynamic team focused on advancing medical technology and improving patient outcomes.

Benefits

Vision insurance

401(k)

Medical insurance

Qualifications

• Minimum of 6 years of experience in the IVD industry.
• At least 3 years focused on preparing and submitting 510(k) for IVD devices.

Responsibilities

• Manage collection of technical data and prepare submissions for regulatory agencies.
• Draft and compile technical documentation for CE / UKCA mark submissions.
• Prepare and submit regulatory documents for FDA approvals.

Skills

Analytical skills

Project management

Multitasking

Education

Bachelors degree in a related field

Tools

Microsoft Office

Job description

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This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

55.00 / hr - $60.00 / hr

Direct message the job poster from BioPhase

Senior Clinical Recruiter at BioPhase Solutions | Life Sciences

• Remote position - Candidates must be located in the United States
• Temporary position

Senior Staff Regulatory Affairs Specialist

As a Regulatory Affairs Specialist, you will manage the collection of technical data and prepare submissions for in vitro diagnostic (IVD) and medical device licenses to regulatory agencies.

• Oversee the submission and review of documents for Design History files.
• Draft, edit, and compile technical documentation and design dossiers to support CE / UKCA mark regulatory submissions.
• Prepare post-market surveillance reports for medical devices.
• Prepare EU / UK vigilance reports as needed.
• Prepare and submit regulatory documents for FDA approvals.
• Assist with the registration and application of Class II & III Medical Device Licenses for Health Canada.
• Research and interpret FDA, CMDR, MDR, IVDR, and UK MDR2002 regulations for regulatory compliance.
• Review and ensure labeling, packaging, and marketing materials meet FDA and CE requirements.
• Maintain and update regulatory documentation and standards.
• Ensure the Essential Requirements Checklists are up-to-date with current standards.
• Provide technical documentation to Competent Authorities and Notified Bodies.
• Support OEM customers in obtaining CE marks for their products.
• Bachelors degree in a related field or equivalent experience.
• Minimum of 6 years of experience in the IVD industry, with at least 3 years focused on preparing and submitting 510(k) for IVD devices.
• In-depth knowledge of medical device regulations.
• Ability to create clear and comprehensive technical documentation.
• Analytical skills with experience in summarizing data.
• Proficiency in Microsoft Office.
• Strong project management and multitasking skills.
• Familiarity with QSRs, ISO 13485, IVDD / IVDR, MDD / MDR, UK MDR 2002, CMDR, GMP, and 21 CFR standards.

Seniority level

• Mid-Senior level

Employment type

• Temporary

Job function

• Other
• Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Vision insurance

401(k)

Medical insurance

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Senior Regulatory Specialist • San Diego, CA, United States