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SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a strong background in Quality Assurance processes, plans and standards.
The Senior Regulatory Affairs Manager, is responsible for supporting New Product Development (NPD) programs as well as day-to-day regulatory activities across dental instrument platforms. The Regulatory Affairs Manager both compiles and provides oversight to RA Associates in the creation of US FDA Submissions, EU or ROW submissions and is a key liaison with International Regulatory Affairs to support applications to global regulatory agencies for new product registrations and re-registrations.
This position is Remote eligible, with up to 25% travel on-site.
Primary Accountabilities
· Reviews and interprets regulations/guidance documents to develop regulatory strategies to support SS White Dental projects (i.e., regulatory submission pathway, predicate device selection, submission requirements, validation approach, timing, risks, etc.).
· Support interaction with US and/or International Regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters.
· Actively lead the regulatory aspects of Technical Documentation/Technical File reviews and conversion to EU MDR requirements for upcoming audits and certification reviews.
· Develop and implement company and departmental SOPs, as required.
· Review critical regulatory documents/submissions and responses to regulatory agencies as needed.
· Represents RA function across projects for both NPD and Sustaining Product Management Teams.
Perform other work-related duties as assigned
Qualifications
Minimum Education/Experience Requirements:
Knowledge, Skills, And Abilities
Why Join SS White Dental
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Full Time
$141k-187k (estimate)
06/06/2024
11/12/2024
sswhitedental.com
Lakewood, NJ
100 - 200
The job skills required for Regulatory Affairs Manager include Regulatory Affairs, Leadership, Innovation, SOP, Communication Skills, Quality Assurance, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Manager. 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 Manager. Select any job title you are interested in and start to search job requirements.
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