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Principal Regulatory Affairs Specialist

  • LocationIrvine, CA 92614 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:17 days ago
  • Job no: 41456
  • Category: Regulatory Affairs

Job Description

One of our top clients is recruiting again! They are looking for a Principal Regulatory Affairs Specialist for their facility. Interested job seekers should have work experience with a highly successful and well-established medical device manufacturer. An overview of the Principal Regulatory Affairs Specialist’s responsibilities:

1) Evaluate proposed and upcoming changes in the global regulatory environment to determine and communicate impact to existing or proposed products as well as overall business impact

2) Maintain current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company

3) Create and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced

4) Provide regulatory strategy and guidance within the cross-functional team and serve as the expert in regulatory affairs for new product development

5) Implement regulatory strategies and ensure timely submissions of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and changes to existing products

6) Maintain and update technical files on a regular basis to ensure compliance to applicable IVD and IVDR regulations and standards

7) Review and generate a gap assessment report on new guidance and standards to provide to management and recommend follow up measures

8) Oversee preparation and compilation of regulatory information requested during government audits and inspections, such as with FDA and notified body

9) Review and assess product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations

10) Identify, communicate and solve regulatory issues that may arise

11) Prepare monthly status reports and KPIs for regulatory affairs management

12) Perform other duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs

If you are qualified and believe you have the ability to excel in this role, this could be your opportunity to work with an excellent and respected company in the medical device industry. Please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience


  • Published on 12 May 2022, 12:51 PM