Regulatory Specialist
Regulatory Specialist (Contract - W2 Only)
Location: Remote (occasional travel within the U.S.)
Contract Length: 2 Years
Hours: 40 per week
Start Date: ASAP
About the Role
A leading global MedTech client is seeking an experienced Regulatory Specialist to support regulatory strategy and submissions for their orthopaedic device portfolio. This is an excellent opportunity for a seasoned regulatory professional with strong PMA and 510(k) experience to contribute to high‑impact medical technologies while working fully remotely.
This role is available on a W2 basis only.
Key Responsibilities
- Prepare, compile, and submit PMA regulatory submissions for orthopaedic devices.
- Conduct regulatory analysis to determine requirements, pathways, and impacts of design or process changes.
- Work cross‑functionally with R&D, Design Engineering, Quality Assurance, and Manufacturing teams to ensure regulatory compliance.
- Support the development, review, and maintenance of Design History File (DHF) documentation.
- Provide regulatory guidance throughout product development and sustaining engineering activities.
- Liaise with the FDA and other regulatory bodies, including drafting responses to requests for additional information.
- Maintain strong knowledge of FDA QSR, ISO 13485, MDR (if applicable), and global regulatory frameworks.
- Participate in risk management activities (ISO 14971) and ensure compliant documentation practices.
- Support labeling, claims review, and verification of regulatory compliance across the product lifecycle.
Required Qualifications
- 5+ years' experience in regulatory affairs within the medical device industry.
- Proven experience preparing 510(k) submissions (traditional, special, abbreviated) and supporting PMA submissions.
- Strong understanding of FDA regulations, design controls, QMS principles, and risk management.
- Experience collaborating with manufacturing, quality, design, and R&D teams.
- Hands‑on involvement in DHF creation, updates, or remediation.
- Excellent analytical, documentation, and communication skills.
- Background in orthopaedics, joint reconstruction, implants, trauma, robotics, or related device fields preferred.
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