Overview
Regulatory Specialist Jobs in Coral Springs, Florida, USA at LifeSync
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Job Title
Regulatory and Post Market Surveillance (PMS) Specialist
Department
Quality
Reports To
Quality and Regulatory Affairs Manager
FLSA
Exempt
Summary
The Regulatory and PMS Specialist supports Life Sync’s regulatory approval process for medical devices, including device/labeling assessments and quality management changes for regulatory implications. This role also handles post-market surveillance activities such as complaints reportability, investigations, trending, and PMS planning and reporting. The person collaborates with Engineering, Manufacturing, Quality, and Marketing teams to ensure product deployment within compliance standards and to identify risks and improvements based on post-market data.
The role is vital in supporting marketing strategies and ensuring products are safe, effective, and compliant with industry standards and regulations, requiring broad regulatory and QMS knowledge.
Responsibilities
Provide regulatory support for US FDA, Health Canada, EU, and other international agencies.
Review products and QMS for compliance with standards and regulations.
Assess complaint information for reportability and investigate complaints, performing trending and analysis.
Conduct post-market surveillance activities, including PSURs and PMSRs per EUMDR and Health Canada requirements.
Support internal and external audits.
Perform additional duties as assigned.
Requirements
Must demonstrate process development and problem-solving skills, ability to multitask, and understanding of US FDA, Health Canada, EU, LATAM, UK regulations. Ability to foster respectful relationships and proficiency in Microsoft Office, ERP, and Microsoft Project are required.
Education
& Experience
Associate degree or higher
At least 2 years of experience in Medical Device functions (Quality, Clinical, Engineering, Regulatory)
Experience with US 510k, Health Canada, and international device submissions and registration
Additional Details
Physical demands are sedentary; comfortable sitting for long periods.
Work environment is typical office setting.
Travel is not required.
Other Information
Seniority level:
Entry level
Employment type:
Full-time
Job function:
Legal
Industry: Medical Equipment Manufacturing
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Title: Regulatory Specialist
Company: LifeSync
Location: Coral Springs, Florida, USA
Category: Healthcare, Quality Assurance – QA/QC
