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Hi,
I hope this week has been kind to you so far. Thought I'd reach out today as I came across your resume, and from what I saw I just had to bring this opportunity to your attention.
At your earliest convenience, please check the job specs out and let me know if this is something you'd like to have an exploratory conversation about.
Job Title: Senior Regulatory Affairs Specialist
Location (Onsite, Remote, or Hybrid?): Temecula, CA (ONSITE)
Contract Duration: contract until 12/31/2024
Working Hours: 8am - 5pm
Description:
Exempt/Non Exempt: Non Exempt
Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Skills:
- Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in
- Have working knowledge in US and EU medical device submissions
- Have experience supporting internal and external inspections Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities
Education: BA Degree
Required Duties:
- This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
- Assist the strategy implementation and operations for Regulatory Affairs activities, product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Update and develop procedures for the Regulatory Affairs in supporting changes in the regulatory landscape, including EU MDR.
- Identify OPPORTUNITY FOR regulatory affair processes and drive changes to completion.
Additional Details
- Start Time (AM/PM) : 8AM
- End Time (AM/PM) : 5PM
- Category : Quality
- Date of Manager Spotlight Call or Exception Reason : Spotlight call will be 3/21 at 3:30 AST (12:30 PST) Microsoft Teams meeting Join on your computer, mobile app or room device Click here to join the meeting Meeting ID: 242 345 350 281 Passcode: KbBiVi Download Teams | Join on the web Join with a video conferencing device teams@mpgv.net Video Conference ID: 118 729 769 1 Alternate VTC instructions Learn More | Meeting options
Kind Regards,
Srota Gomati
Senior Technical Recruiter
Phone (332) 217-1878 ext. 1087
Email srotag@techlinksystems.com
TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.
We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.
We also have national recruiting centers that service our enterprise and MSP/VMS clients. We are a Secret Cleared Facility and our core competencies are Information Technology, Engineering, Customer Service/Call Center, Admin/Clerical, Finance/Accounting, Scientific/Clinical, Sales/Marketing, Legal, Human Resources, Light Industrial (limited), and Professional across a range of industries.
The company’s talented Recruiters and HR Specialists have backgrounds in many cutting-edge, high-performance industries making TechLink Systems an ideal partner for recruitment process outsourcing.
We look forward to our partnership with you!
