2 Principal Regulatory Affairs Specialist Jobs in Campbell, CA
Sorry! This job is no longer available. Please explore similar jobs listed on the left.
Telos Health, Inc. is Hiring a Principal Regulatory Affairs Specialist Near Campbell, CA
- Support business objectives by executing on the company’s regulatory strategy and prioritie
- Represent Regulatory discipline in Project Teams: advise on bench, animal, and human clinical test plans, review and approve Design Control deliverables, provide information and advice to ensure regulatory risks, benefits, and timelines are understood
- Develop US and OUS regulatory strategies, including predicate device identification, for products in development
- Prepare regulatory documents and filings such as Letter-To-File, Pre-Submission, 510(k), IDE, PMA, Technical Documentation File, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines
- Partner with Clinical in development of clinical strategy; review and approve trial protocols and reports and associated documentation
- Serve as the main contact to regulatory agency reviewers on submissions, coordinate with internal team members to respond to deficiency questions, and negotiate with regulatory agency reviewers for outcomes favorable to Imperative Care
- Review and approve Document Change Order requests, CAPAs, NCRs, Complaints, etc.
- Prepare various presentations to regulatory agency reviewers and/or inspectors as needed
- Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols
- Compile regulatory intelligence tracking for competitor products
- Develop appropriate procedures for the regulatory function
- Provide regulatory information for management review
- BS in related discipline and 12 years of related experience; or MS in related field with 8 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
- Experience in preparing US and/or OUS regulatory submissions, change order assessments
- An advanced degree is desirable, neurovascular product experience a plus
- Excellent written and oral communication skills; technical writing capabilities are a must
- Action-oriented style must be evident
- Ability to exercise independent judgment and decision making for routine programs
- RAC certification a plus
- Ability to prioritize multiple projects independently
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
Job Summary
Full Time
$91k-120k (estimate)
03/27/2024
04/24/2024
teloshealth.com
San Francisco, CA
<25
Related Companies
The job skills required for Principal Regulatory Affairs Specialist include Regulatory Affairs, SOP, Presentation, Technical Documentation, Oral Communication, Technical Writing, etc. Having related job skills and expertise will give you an advantage when applying to be a Principal 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 Principal Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Principal Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Principal 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 Principal Regulatory Affairs Specialist. You can explore the career advancement for a Principal Regulatory Affairs Specialist below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
