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Regulatory Affairs Specialist

Campbell, CA | Full Time
9 Days Ago

Job Description

SUMMARY:  Partner with Imperative Care functional groups to efficiently deliver accurate, timely, and effective regulatory documents, deliverables and other projects in line with company objectives, policies and procedures.   Provide regulatory guidance with various ongoing cross-functional projects in order to remain in compliance with all FDA and other U.S. and international regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  

  • Serve as the regulatory team member on core teams engaged in the development of new products, ensuring that regulatory requirements are fully understood by the core team and incorporated and/or mitigated in the new product project plan
  • Assess regulatory impact of design, manufacturing, labeling, and facility changes and prepare any associated submissions
  • Review plans, protocols, reports, and labelling to ensure compliance with regulations and ensure sufficiency of documentation for regulatory filings
  • Develop and document regulatory strategies with assistance from management
  • Draft and submit regulatory applications such as Pre-submission requests and 510(k)s and any corresponding follow up under management supervision
  • Document product changes in Letters-To-File as needed per regulatory requirements
  • Direct reviewer/agency interactions under management supervision
  • Maintain product Technical Document(s) compliant with EU MDR
  • Facility registrations and device listings with FDA

EDUCATION/EXPERIENCE:                                                                                                                     

  • Minimum Bachelor’s degree in science-related field or equivalent required
  • Experience in preparing US and/or OUS regulatory submissions, change order assessments
  • Neurovascular product experience a plus 
  • Excellent written and oral communication skills; technical writing capabilities are a must
  • Action-oriented style must be evident
  •  RAC certification a plus
  • Ability to prioritize multiple projects independently

SUPERVISORY RESPONSIBILITIES:                                                                                                        
None

Company Overview

  • Website imperativecare.com
  • Headquarters CAMPBELL, CA
  • Size 50 - 100
  • Founded 2015
  • Type
  • CEO DANIEL DAVIS
  • Revenue <$5M
  • Industry Biotechnology
  • About imperative care

Skills for Regulatory Affairs Specialist

The job skills required for Regulatory Affairs Specialist include Oral Communication, Technical Writing etc. Having related job skills and expertise will give you an advantage when applying to be a 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 Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.

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Career Path for Regulatory Affairs Specialist

The following is the career advancement route for Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist, 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 Affairs Specialist. You can explore the career advancement for a Regulatory Affairs Specialist below and select your interested title to get hiring information.