Med Device Regulatory Affairs Specialist – Hybrid

Actalent; Fort Worth (TX); Hybrid; USD 95.000 - 110.000; Vollzeit

Benefits dieser Stelle

401k

Medical insurance

Dental insurance

Vision insurance

Zusammenfassung

Actalent in Fort Worth, TX, seeks a Regulatory Affairs Specialist to prepare and submit regulatory documents for medical devices, ensuring compliance with FDA QMSR, 21 CFR Part 820, and EU MDR. The role supports audits, CAPA, PMS, CER, and PMCF activities while guiding regulatory strategies for global products.

You will collaborate with Manufacturing, Product Development, Marketing, and Sales to ensure compliant processes and product claims, and stay ahead of evolving regulatory requirements in

Qualifikationen

• Bachelor's degree in a scientific, engineering or pre-law field.
• Minimum 2 years in quality assurance or regulatory affairs within medical devices.
• Experience with medical device regulatory submissions, including 510(k).
• Knowledge of FDA QMSR and 21 CFR Part 820.
• Familiarity with EU MDR and ISO quality standards.
• Strong documentation and recordkeeping accuracy.
• Excellent written and verbal communication; strong organizational skills.

Aufgaben

• Prepare, compile, and submit regulatory documents for product registrations.
• Support compliance with regulatory requirements for medical devices globally.
• Assist audits and CAPA activities.
• Monitor regulatory changes and communicate impact to stakeholders.
• Collaborate with Manufacturing, Product Development, Marketing, and Sales.

Kenntnisse

Regulatory submissions (510(k))

FDA QMSR & 21 CFR Part 820

EU MDR compliance

CAPA management

Cross-functional collaboration

Documentation & recordkeeping

Excellent communication

Ausbildung

Bachelor's degree in a related field such as scientific discipline, engineering, or pre-law

Tools

Microsoft Office

Regulatory software

Jobbeschreibung

Actalent in Fort Worth, TX, seeks a Regulatory Affairs Specialist to prepare and submit regulatory documents for medical devices, ensuring compliance with FDA QMSR, 21 CFR Part 820, and EU MDR. The role supports audits, CAPA, PMS, CER, and PMCF activities while guiding regulatory strategies for global products.

You will collaborate with Manufacturing, Product Development, Marketing, and Sales to ensure compliant processes and product claims, and stay ahead of evolving regulatory requirements in