Associate Regulatory Affairs Specialist - Onsite
$60,800–$91,200 year
On-siteFort Worth, Texas, United States
Job Summary
Support regulatory activities related to the medical device Total Product Lifecycle, including product maintenance and global submissions. Manage changes to labeling, manufacturing, marketing, and clinical documentation to ensure regulatory compliance. Compile materials for submissions, license renewals, and annual registrations while supporting preparation of document packages for regulatory submissions, internal audits, and inspections. Monitor and improve tracking/control systems and keep abreast of regulatory procedures and changes. May participate in interactions with regulatory agencies on defined matters. Work onsite minimum of 4 days a week. Salary range $60,800 - $91,200. Unrestricted U.S. work authorization required.
Required Qualifications
- Baccalaureate degree
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
Desired Qualifications
- Open to feedback and continuous improvement
- Experience/knowledge of MS Office Suite
- Strong critical thinking and cross-functional collaboration skills
- Ability to synthesize regulatory information for clear stakeholder communication
- Self-starter with strong accountability and independent work style
- Strong organizational skills with the ability to manage shifting priorities while maintaining quality and accuracy
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.