Medcomp is Hiring!
Searching for an experienced Regulatory Affairs Associate to join the TEAM!
VISION & MISSION STATEMENT
To be the leading solution provider for every customer we serve.
To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services.
About Us - Medcomp® develops, manufactures, markets and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies.
Summary: Oversees/Manages the regulation process for products requiring regulatory agency licensing, registration or clearance, including filing necessary applications/submissions. Coordinates the accumulation of technical information and creates submissions for medical devices for approval, license, registration or clearance in any region:
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Responsible for providing international (EU MDR and Health Canada) and domestic regulatory input to the development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.
Responsible for the interactions with the FDA, the EU Notified Body, and Health Canada. Keep updated on all country requirements and changes.
Participate in change control meetings. Review and approve requests. Notify Regulatory Bodies of changes that impact clearances, licenses, etc.
Perform labeling reviews/approvals as required.
Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions.
Create and maintain registrations procedures/protocols.
Work closely with internal and external customers to achieve success.
Additional duties and/or modifications to job description may occur at any time.
Create 510(k) submissions for Domestic Market (FDA). Submit Q-Submission Meetings, such as pre-submission and issue meetings, to the FDA as needed.
Create Technical Files, Design Dossiers and Health Canada notifications of product changes for submission to the designated Regulatory Agency to obtain/maintain CE Marking.
Review and Maintain (MDD) Technical Files and Design Dossier/(MDR) Technical Documentation after receiving CE Marking.
Create New License Submissions, Amendments, and Fax Back applications for Health Canada.
Respond to questions from regulatory agencies during review/submissions.
Support and assist with the external audit program and participate in inspections and audits by Regulatory Bodies.
Complete Regulatory Corrective and Preventive Actions generated from audit findings.
Develop and maintain policies and procedures regarding to regulatory submissions and processes.
Create and maintain, a foreign registration database of all current in country registrations and licenses.
Partnering with International regulatory contacts to understand requirements for product registrations for new and modified products.
Partnering with International regulatory contacts to plan, develop and submit product registration applications for new and modified products.
Coordinate with testing facilities to support submissions and testing requirements.
Attend or lead Regulatory meetings.
Education: Bachelor's degree (B. A./B.S.) from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.
Certificates, Licenses, Registrations: RAC certification is preferred.
Other Skills and Abilities: Knowledge and understanding of US, EU MDR and international medical device regulations.
Visa Sponsorship is not available for this position.
Job Type: Full-time
- Regulatory: 2 years (Required)
- 510(k): 2 years (Required)
- FDA, EU, MDR: 2 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Flexible schedule