What are the responsibilities and job description for the Regulatory Affairs Specialist position at Stark Pharma Solutions Inc?
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
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.
You can also follow Stark Pharma Solutions on LinkedIn for the
Latest Job Updates
https://www.linkedin.com/company/99455976/
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.
- Bachelor's 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.
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.
You can also follow Stark Pharma Solutions on LinkedIn for the
Latest Job Updates
https://www.linkedin.com/company/99455976/