What are the responsibilities and job description for the Regulatory Affairs Specialist position at ACE Partners?
Regulatory Affairs Specialist – Medical Device Industry - $80k - $85k
Remote - Pocopson, PA
US Citizen or Green card holders only
No C2C
A leading medical device technology company is seeking a Regulatory Affairs Specialist to join their team. You will specialize in the design and manufacturing of cutting-edge spinal implants and surgical instrumentation.
Their commitment to innovation, quality, and excellence has made them a trusted name in the industry.
What You Will Do:
- Ensure regulatory compliance by implementing and maintaining internal procedures aligned with industry standards and regulations.
- Support daily regulatory affairs activities under the guidance of the RA/QA manager.
- Maintain compliance with ISO 13485, FDA, and international regulatory requirements through quality assurance procedures and audits.
- Act as a liaison with regulatory agencies to ensure full compliance with US and international regulations.
- Assist in FDA inspections, Notified Body audits, and internal audits; contribute to audit responses and corrective actions.
- Manage and update US and international regulatory registrations and licenses.
- Represent regulatory affairs in project planning and design control meetings.
- Track and report on FDA submissions, ISO 13485 compliance, and design deliverables.
- Provide regulatory guidance on device packaging labels, Instructions for Use (IFUs), promotional materials, and sales training content.
- Review and audit FDA premarket submissions, including 510(k) Premarket Notifications.
Requirements:
- Bachelor’s degree in a scientific or engineering field or equivalent experience.
- 5 years of experience in regulatory affairs within the medical device industry.
- Experience leading FDA inspections and ISO audits is a plus.
- Strong knowledge of FDA regulations, CE marking, risk analysis, and ISO standards.
- Experience with 510(k) submissions, Investigational Device Exemptions (IDEs), and Premarket Approval Applications (PMAs).
- Proficient in MS Office and CAD software (Creo preferred).
- Understanding of ISO 13485, ISO 14971, cGMP, and other medical device quality systems (certifications a plus).
- Familiarity with FDA Unique Device Identification (UDI) regulations and GS1 data standards is beneficial.
- Ability to use calipers, micrometers, and mechanical inspection tools (RAM and Overlay experience a plus).
- Strong attention to detail, problem-solving skills, and a team-oriented mindset.
Salary : $80,000 - $85,000
