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Imperative Care
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Regulatory Affairs Specialist
Imperative Care Campbell, CA
Full Time | Medical Technology 6 Months Ago
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Imperative Care is Hiring a Regulatory Affairs Specialist Near Campbell, CA

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

Job Summary

JOB TYPE

Full Time

INDUSTRY

Medical Technology

POST DATE

09/18/2022

EXPIRATION DATE

12/15/2022

WEBSITE

imperativecare.com

HEADQUARTERS

CAMPBELL, CA

SIZE

50 - 100

FOUNDED

2015

TYPE

Private

CEO

DANIEL DAVIS

REVENUE

<$5M

INDUSTRY

Medical Technology

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About Imperative Care

Imperative Care is a California-based medical device company that develops and manufactures neurovascular products for physicians.

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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 Manager 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.