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· The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit.
· In this role you will prepare documentation for EU Technical Files and international product registrations.
· This job description will be reviewed periodically and is subject to change by management.
Responsibilities:
· Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
· Provides regulatory support for diagnostic product development and commercial diagnostic products.
· Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
· Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
· Researches and communicates scientific and regulatory information in order to write submission documents.
· Compiles and publishes all material required for submissions, license renewals, and annual registrations.
· Maintains approvals/licenses/authorizations for existing marketing authorizations.
· Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
· Develops internal procedures and tools.
· Conducts informational or training sessions for stakeholders.
· Organizes and maintains hard copy and electronic department files.
· Demonstrates commitment to the development, implementation and effectiveness of our Quality Management System per ISO, FDA, and other regulatory agencies.
· Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Basic Qualifications | Education:
· Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
· 4 years’ experience in Regulatory Affairs role.
· Strong knowledge of IVDR and EU regulatory requirements is required.
Preferred Qualifications:
· 1 years’ experience in an IVD or medical device manufacturing environment.
Competencies:
· Good knowledge of EU and international regulations.
· Demonstrated written and verbal communication skills.
· Strong time management skills, with the ability to work on multiple projects simultaneously.
· Ability to work independently as well as within a team.
· Proficiency with MS Office, including Word, Excel, PowerPoint and Visio
Contractor
IT Outsourcing & Consulting
$69k-91k (estimate)
07/17/2024
09/15/2024
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 Regulatory Specialist II include Regulatory Affairs, Product Development, ISO, Chemistry, Verbal Communication, Time Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Specialist II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Specialist II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Specialist II positions, which can be used as a reference in future career path planning. As a Regulatory Specialist II, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Specialist II. You can explore the career advancement for a Regulatory Specialist II below and select your interested title to get hiring information.