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· Perform assigned regulatory activities including submissions/responses to country authorities.
Daily Responsibilities - Job Description suppliers should use:
· Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.
· Assist in strategy implementation and operations for regulatory affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.
· Assist in maintaining Regulatory records and files.
· Review product changes as assigned and assess required EU MDR submissions/notifications.
Educational Requirements:
· BA Degree required, preferably in a science, engineering or technology discipline.
· Work Experience Requirements: 3-5 years experiences in Medical Device Regulatory Affairs Top
Skills:
· Strong oral communication and interpersonal skills
· Proficient in technical writing
· Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.
· MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and monitoring these/Conditional Formatting.
Contractor
IT Outsourcing & Consulting
$95k-121k (estimate)
06/19/2024
08/17/2024
collabera.com
REDMOND, WA
3,000 - 7,500
2005
ADITI OGALE
$500M - $1B
IT Outsourcing & Consulting
We are engineering technology & talent. At Collabera, we built our business and our reputation by servicing the engineering solutions and talent development needs of our clients. That experience helped make us who we are todaypartners with the worlds most forward-thinking organizations, designing, building, operating and automating the technology that powers their businesses. Every solution we provide is delivered with speed, scale, quality, and flexibility, and powered by our AI-driven, Cloud-based technology and talent platforms. And, while weve expanded our offerings to meet the evolving ne...eds of our software engineering clients, we havent forgotten where we came fromwere still committed to building the tech workforce of the present and the future through our best-in-class training and enablement services. In other words, were driven by tech and backed by talent. Its that human-centric approach that makes us unique. And it reminds us that relationships are always the most important things we build. So, whether you need innovative technology talent solutions, or youre looking for opportunities to work with todays most tech-forward organizations, partner with usand let us help your business or your career get to the next level.
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The job skills required for Senior Regulatory Affairs Specialist include Regulatory Affairs, Technical Writing, Oral Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
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