Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
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
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