JointMedica is a growing company in the medical device sector that designs and manufactures several implantable orthopaedic devices and their associated surgical instruments.
About the Role
The Regulatory Associate role is critical in ensuring that the company's medical devices meet all necessary regulatory and quality standards while supporting the development and commercialization of hip resurfacing and total hip arthroplasty implants. Reporting to the VP of Quality Assurance and Regulatory Affairs, this position is responsible for regulatory compliance, regulatory strategy, and engagement with regulatory bodies globally. This position offers a unique opportunity to impact the development and compliance of innovative orthopaedic devices, with a focus on regulatory excellence and quality assurance leadership.
The primary responsibilities include:
1. Regulatory Compliance: Ensure compliance with FDA, ISO (e.g., ISO 13485), and other international regulations; develop and oversee internal systems to meet regulatory requirements.
2. Regulatory Strategy Development: Create and align regulatory strategies with commercial goals for market entry, prioritizing key clearances as per the Global Regulatory plan.
3. Submission Preparation: Manage projects related to new product introductions, prepare technical files and design dossiers for submissions, and support regulatory applications like 510(k), PMA, and IDEs.
4. Regulatory Intelligence & Liaison: Stay updated on regulatory trends, serve as the main contact for agencies, and manage communications and audits.
5. Risk Management & Compliance Audits: Contribute to risk mitigation programs and participate in compliance audits.
6. Post-Market Surveillance & Clinical Integration: Support clinical surveillance, generate evaluation reports, and assist in updating surgical techniques based on clinical data.
7. Design and Development Input: Use clinical insights to guide design refinements and maintain design history files.
Requirements
Required skills and qualifications:
* Bachelor's degree in biomedical engineering, life sciences, or relevant experience.
* Strong knowledge of FDA regulations (21 CFR 820), ISO standards, and international regulations.
* Proficiency in regulatory submissions including 510(k), PMA, and Technical Files.
* Analytical problem-solving and decision-making skills.
* Proficiency with database management and QA tools.
* Excellent communication skills for internal and external interactions.
* Understanding of medical device industry trends and technologies.
* Experience with hip resurfacing or total hip arthroplasty devices is advantageous.
* Ability to manage regulatory processes from development to post-market.
* Experience collaborating with external consultants and regulators for global market entry.
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