1 Job in Redwood City, CA
Katalyst Healthcares & Life Sciences is Hiring a Regulatory Affairs Specialist II Near Redwood City, CA
- You are responsible for regulatory submissions and regulatory compliance for currently marketed products, as necessary, to ensure ongoing compliance
- Regulatory representative on core teams providing regulatory input and guidance throughout the product development cycle.
- Work on development of pre-submission strategy/regulatory pathway, provide input on testing requirements for new and modified product.
- Assess software, product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required for applicable geographies; analyze and recommend appropriate changes.
- Responsible for preparation and submission of regulatory applications and reports for FDA, EU and other regulatory agencies, as well as internal regulatory file documentation.
- Work closely with cross functional team members in quality, clinical and R&D as required on projects to write submissions as well as resolve regulatory agency questions. Review and sign-off on product and manufacturing changes for compliance with applicable regulations.
- Keep abreast of regulatory procedures and changes as well as evolving regulatory landscape. Actively participates in problem solving discussions and recommends solutions. May require direct interaction with regulatory agencies on defined matters. Provide support during internal and external audits
- Support and maintain Quality initiatives in accordance with Nevro Quality Policy.
- Bachelor's/Advanced degree and minimum 2 years of experience in medical device regulatory Affairs Experience with Class II/III medical devices (510(k), PMA, IDE)
- Experience working on EU MDR submissions/amendments preferred Software as a Medical Device (Sam D) experience preferred This position is based at Nevro HQ location Working knowledge of FDA, EU MDR, and international regulations for medical devices.
- General understanding of product development process and design control. Ability to comprehend and apply principles of engineering, physiology, and medical device useability to effectively manage multiple projects and priorities Effectively research and analytical thinking skills.
- Effective team members Effective written and oral communication, technical writing and editing skills. Ability to work independently with minimal supervision Proficiency with Microsoft Office.
Job Summary
Full Time
$79k-103k (estimate)
12/29/2022
05/19/2024
katalysthls.com
South Plainfield, NJ
<25
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The job skills required for Regulatory Affairs Specialist II include Regulatory Affairs, Regulatory Compliance, Product Development, Initiative, Problem Solving, Oral Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs 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 Affairs Specialist II. Select any job title you are interested in and start to search job requirements.
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