Trumbull, United States
over 1 year ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
We are currently seeking a Regulatory Affairs Specialist (IVDs) in Trumbull, CT. or remote
Position Summary and Special Duties:
As a (an) Regulatory Affairs Specialist (IVDs) your day-to-day duties will consist of and may not be limited to: 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 including in vitro diagnostics (IVDs) for approval, license, registration, or clearance in any region.
Essential Duties and Responsibilities include the following:
- Responsible for performing CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and rest of the world (ROW).
- Responsible for 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/IVDR) 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, modified products and/or registration renewals.
- Coordinate with applicable stakeholders, to support submissions and testing requirements.
- Attend and/or lead Regulatory meetings.
- 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/IVDR and international medical device regulations.
• Regulatory: 5 years (Required)
• IVDs 510(k): 2 years (Required)
• FDA, EU, Canada: 4 years (Required)
- Duration: Direct hire
- Location: Trumbull, CT. or remote
- Salary: depending on experience
- Benefits: yes
- Shift: Office: 8AM- 4:30PM
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.