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Regulatory Affairs Specialist

5 months ago

New Freedom, United States Sterling Life Sciences Full time

Job Description

One of our top clients is recruiting again They are looking for a 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 Regulatory Affairs Specialist's responsibilities:

1) Be responsible for international regulatory submissions and regulatory compliance for FDA

2) Maintain regulatory, registrations, declaration of conformity, certificates of import, product updates, fees, correspondence, and reports

3) Submit requests to pay all regulatory fees on a timely basis and maintain regulatory costs for the RA budget

4) Response to international sales requests

5) Partner with the New Product Development and Engineering team to ensure design, technical files, service, and user manuals meet international requirements

6) Manage UDI database, labeling compliance, assess/develop proposed new or product/labeling changes and obtain clearances and approvals as required

7) Maintain ISO standards

8) Oversee audit schedule and auditors and ensure audits are completed to schedule

9) Upload audit action items into QT9, assign responsibility and due dates and monitor for timely closure

10) Review and communicate resulting issues to the Management Team for any corrective actions

11) Facilitate timely closure of corrective actions with appropriate documented evidence

12) Support departmental efforts toward the achievement of company targets

13) Maintain cooperative, professional behavior with everyone they come into contact with

14) Understand and follow the company's safety rules, policies, and procedures

15) Provide suggestions to improve quality and efficiency

16) Maintain proprietary and confidential company information

17) Report to work when scheduled and in a timely manner

18) 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

indmed

  • Published on 07 Sep 2023, 1:57 PM