Regulatory Affairs Specialist II
Job Posting for Regulatory Affairs Specialist II at BioTalent
Regulatory Affairs Specialist II
BioTalent Andover, MA
About the job
BioTalent is partnered with a cutting edge medical device manufacturer seeking a driven Regulatory Affairs Specialist to join their growing team on a hybrid basis.
POSITION OVERVIEW :
As a Regulatory Affairs Specialist , you will play a crucial role in securing regulatory approvals for class I-III devices through the FDA and European Standards.
You will work closely with cross-functional teams to strategize, prepare, and submit regulatory submissions in accordance with FDA and EU / MDR regulations.
RESPONSIBILITIES :
Regulatory Submissions :
- Prepare, compile, and submit regulatory documents for product registrations, 510(k) submissions, and other regulatory filings.
- Ensure timely and accurate submissions in compliance with FDA and international regulatory requirements (EU / MDR, Health Canada, etc).
Regulatory Strategy :
- Collaborate with product development teams to develop and implement regulatory strategies for new and existing products.
- Provide regulatory guidance to ensure compliance throughout the product lifecycle.
Communication with Regulatory Agencies :
- Establish and maintain positive relationships with regulatory authorities.
- Respond to regulatory inquiries and provide necessary documentation.
Quality Management Systems (QMS) :
- Contribute to the development and maintenance of the QMS to ensure regulatory compliance.
- Participate in internal and external audits related to regulatory affairs.
Regulatory Intelligence :
- Stay current on changes to regulatory requirements and industry standards.
- Communicate regulatory updates to internal stakeholders.
Qualifications :
- 5 years of experience in regulatory affairs within the medical device industry.
- Solid understanding of FDA regulations, ISO 13485, and other relevant quality standards.
- Experience with 510(k) submissions, CE marking, and international regulatory processes.
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