Regulatory Affairs Specialist

Hi

My name is Sravani Dasari and I am a Talent Acquisition Specialist with
Stark Pharma Solutions specializing in opportunities across the
Pharmaceutical Biotechnology Medical Device and Life Sciences industries.

Job Title: Regulatory Affairs Specialist
Location: Springfield IL
Duration: Long Term

Position Overview

We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to support regulatory compliance activities for medical device products. The ideal candidate will be responsible for preparing regulatory submissions maintaining product registrations ensuring compliance with FDA and international regulations and collaborating with cross-functional teams throughout the product lifecycle.

Key Responsibilities

• Prepare review and submit regulatory documents for product registrations renewals and amendments.
• Support FDA submissions including 510(k) Technical Files and other regulatory filings as required.
• Ensure compliance with FDA ISO 13485 MDR and other applicable medical device regulations.
• Maintain regulatory documentation and product registration records.
• Monitor and interpret changes in regulatory requirements and communicate impacts to internal teams.
• Collaborate with Quality R&D Manufacturing and Clinical teams to support product development and commercialization.
• Assist with audits inspections and responses to regulatory authorities.
• Support labelling reviews and regulatory assessments for product changes.

Required Qualifications

• Bachelors degree in Regulatory Affairs Life Sciences Biomedical Engineering or a related field.
• 2 years of experience in Regulatory Affairs within the Medical Device industry.
• Knowledge of FDA regulations 21 CFR Part 820 ISO 13485 and global regulatory requirements.
• Experience preparing and managing regulatory submissions.
• Strong documentation analytical and organizational skills.
• Excellent written and verbal communication abilities.
• Proficiency with Microsoft Office and regulatory document management systems.

I am actively connecting with professionals for current and
upcoming opportunities. If you are open to exploring new roles or would like to
stay informed about relevant positions please send me your updated resume
along with the best number and time to reach you.

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