Regulatory Affairs Specialist - Medical Devices

Position Summary/Role and Responsibilities:

• Support in the preparation and submission of regulatory submissions in accordance with organizational objectives
• Develop and maintain EU Technical Documentation
• Maintain device listings and registrations
• Assess complaint reportability and file adverse event reports when required
• Maintain/manage standards compliance
• Review engineering change orders and assess regulatory impact
• Act as a regulatory representative on product development teams and communicate regulatory requirements
• Monitor and maintain ongoing surveillance and analysis of pertinent domestic and international medical device regulations, standards and guidances
• Assist in maintenance of Quality Management System
• Conduct internal/supplier audits
• Maintain regulatory files and records
• Additional responsibilities as assigned

Supervisory Responsibilities: N/A

Qualifications and Education Requirements

· BA or BS degree; Scientific or engineering field preferred.

· 1-2 years of technical experience, including at least 1 years of regulatory experience in a medical device industry

· Experience with 510(k), IDE, PMA applications and/or experience with EU and other international medical device submissions

· Must have knowledge of U.S. and/or European/International regulations and standards

· Experience in preparing regulatory submissions.

Knowledge/Skills:

· Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

· Must demonstrate good technical writing skill

· Must work well in team environments

· Proficient on programs under Microsoft office; proficient in formatting submission documents

· Proven analytical abilities

· FDA 510k, PMA regulations

· EU MDR requirements

Preferred Skills

RAC Certification

Working Conditions:

Typical office work related activities.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Parental leave
• Retirement plan

Schedule:

• Monday to Friday

Work Location: In person