3 Regulatory Affairs Specialist (Must Have Medical Device Regulations) Jobs in Franklin, NJ
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millenniumsoft is Hiring a Regulatory Affairs Specialist (Must Have Medical Device Regulations) Near Franklin, NJ
Responsibilities
- Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal Letter to File (U.S.) for changes that do not require a 510(k) submission, and assess also for EU impact.
- Support preparations of technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
- Support notifications to the Notified Body about significant changes to CE marked products in a timely manner.
- Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
- Represent RA in product life cycle development and/or new product development teams by reviewing, approving, and completing requirements.
- Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
- Support International Registrations as it relates to product changes and/or new product launches.
- Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
- Create and maintain regualtory performance metrics.
- Identify opportunities to improve the existing process and implement the improvements.
- Work with Regulatory Supervisor to execute large scale projects.
EducationB.S. degree or higher in a life science or technical discipline, preferably in biology, or chemistry, engineering, bioengineering and regulatory affairs. Licenses/Certifications: RAPS Certification is a plus
Experience
- Minimum of 5 years regulatory affairs experience in medical device regulations, or 3 years of experience with an advanced degree.
- Understanding of US, EU and international medical device and IVD regulatory requirements.
- Proficient in using various computer/Microsoft Office programs.
- Strong oral and written communication skills.
- Project management skills.
- Handle multiple tasks and prioritization skills.
- Strong attention to details.
Job Summary
Contractor
IT Outsourcing & Consulting
$85k-111k (estimate)
06/05/2024
08/19/2024
gomillenniumsoft.com
FAIRFAX, VA
50 - 100
2000
SHAILAJA MASHETTY
$5M - $10M
IT Outsourcing & Consulting
Related Companies
The job skills required for Regulatory Affairs Specialist (Must Have Medical Device Regulations) include Regulatory Affairs, Written Communication, Problem Solving, Microsoft Office, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist (Must Have Medical Device Regulations). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist (Must Have Medical Device Regulations). Select any job title you are interested in and start to search job requirements.
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