Regulatory Affairs Specialist (Remote US)

This role will be responsible for preparing and coordinating regulatory documentation, maintaining regulatory records, and supporting global regulatory operations to ensure compliance with applicable regulations. We are seeking experienced Regulatory Affairs Specialists to support regulatory submissions and compliance activities for medical device products.

100% remote role
Position Summary
We are seeking experienced Regulatory Affairs Specialists to support regulatory submissions and compliance activities for medical device products. This role will be responsible for preparing and coordinating regulatory documentation, maintaining regulatory records, and supporting global regulatory operations to ensure compliance with applicable regulations.
 
Key Responsibilities

• Coordinate and prepare regulatory submission packages and supporting documentation.
• Compile, review, and organize documentation required for regulatory submissions.
• Support regulatory projects, product changes, and business initiatives.
• Maintain accurate regulatory records and update regulatory databases and tracking systems.
• Monitor submission timelines and improve document control and tracking processes.
• Stay current with evolving regulatory requirements and industry standards.
• Support internal audits, inspections, and regulatory compliance activities.
• Collaborate with cross-functional teams including Quality, Engineering, R&D, Manufacturing, and Operations.
• Communicate with regulatory authorities on assigned activities, as needed.

 
Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, or a related technical field.
• 2–5 years of Regulatory Affairs experience within the medical device industry.
• Experience preparing and coordinating regulatory submissions.
• Knowledge of medical device regulations and regulatory submission processes.
• Strong documentation, organization, and project coordination skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced, regulated environment.

 
Preferred Qualifications

• Experience supporting regulatory audits and inspections.
• Familiarity with regulatory document management and tracking systems.
• Experience working with global cross-functional teams.
• Strong attention to detail and problem-solving skills.

 
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”