Medical Device Regulatory Affairs Specialist

Actalent; Miami (FL); On-site; USD 47,000 - 56,000; Full time

Job summary

Actalent is seeking a Regulatory Affairs Specialist to support regulatory compliance, product registrations, and submissions for medical devices in the U.S. and internationally. Based in Kendall, FL, this role offers exposure to QA, R&D, and regulatory teams in a growing medical device organization.

The ideal candidate has strong regulatory knowledge, excellent writing skills, and comfort coordinating with agencies across markets; bilingual English/Spanish is a plus.

Qualifications

• Bachelor's degree in Engineering, Regulatory Affairs, or related technical field.
• 13 years regulatory experience preferred; strong entry-level candidates considered.
• Knowledge of FDA regulations and medical devices.
• Experience with regulatory documentation and document control.
• Strong technical writing, organization, and attention to detail.
• Bilingual English/Spanish.
• RAPS certification is a plus.
• Authorized to work in the United States; no visa sponsorship.

Responsibilities

• Prepare and coordinate documentation for regulatory submissions (FDA 510(k), PMA, EU TD).
• Maintain regulatory documentation for medical devices.
• Support FDA adverse event and international vigilance reporting.
• Manage medical device registrations in applicable markets.
• Coordinate with regulatory agencies on defined matters.
• Partner with R&D, Engineering, Quality, Operations, Sales, and Marketing.
• Assist in developing regulatory strategies for new products.
• Support internal audits and regulatory inspections.
• Stay current on applicable medical device regulations and standards.

Skills

Regulatory knowledge

Regulatory submissions

Technical writing

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in Engineering, Regulatory Affairs, or related field

Job description

Actalent is seeking a Regulatory Affairs Specialist to support regulatory compliance, product registrations, and submissions for medical devices in the U.S. and internationally. Based in Kendall, FL, this role offers exposure to QA, R&D, and regulatory teams in a growing medical device organization.

The ideal candidate has strong regulatory knowledge, excellent writing skills, and comfort coordinating with agencies across markets; bilingual English/Spanish is a plus.