Regulatory & Compliance Specialist jobs in United States
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Specialized Recruiting Group - Dubuque, IA ยท 4 days ago

Regulatory & Compliance Specialist

positionDubuque County, IA
timeFull-time
remoteOnsite
seniorityNew Grad, Entry Level
money$65K/yr - $80K/yr

Specialized Recruiting Group is searching for candidates on behalf of a local manufacturing company for a Regulatory & Compliance Specialist. This role focuses on supporting regulatory compliance with FDA and ISO standards and involves maintaining regulatory documentation and collaborating with various teams.

Staffing & Recruiting
Hiring Manager
Molly Wand
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Responsibilities

Support regulatory compliance with FDA, ISO, and applicable international standards
Assist with licensing, registrations, permits, and regulatory submissions (including 510(k) support)
Maintain regulatory documentation, files, and databases to ensure ongoing compliance
Partner with Quality and Engineering teams to review product changes, labeling, IFUs, and technical documentation
Monitor new and evolving regulations and communicate impacts to internal teams
Participate in internal and external audits and support CAPA activities
Assist with complaint reviews, post-market surveillance, and regulatory reporting
Respond to customer, regulatory agency, and third-party information requests

Qualification

Regulatory complianceFDA knowledgeISO standardsRegulatory submissionsAttention to detailCross-functional collaborationEffective communication

Required

Bachelor's degree in Engineering, Healthcare, Biomedical Science, Biology, Chemistry, or a related science field
Strong attention to detail and documentation skills
Ability to collaborate cross-functionally and communicate effectively

Preferred

Experience in regulatory affairs, quality, or a regulated industry is helpful but not required
Preference for candidates with local ties or who currently live in the area

Benefits

Medical
Dental
Vision
Life
Disability
401(k) with employer match

Company

Specialized Recruiting Group - Dubuque, IA

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Specialized Recruiting Group of Dubuque: Tailored Solutions for Job Seekers and Employers Job Seekers: Your career journey is unique, and your job search should reflect that.
dateFounded in 2007
location
Dubuque, Iowa, US
people-size11-50 employees
web-link
https://www.expresspros.com/DubuqueIASRG/

Funding

Current Stage
Early Stage
Company data provided by crunchbase