Achieve global impact in regulatory affairs with a leading orthopedic company. As a Regulatory Affairs Program Manager, you’ll play a pivotal role in guiding our medical technologies through regulatory approvals, ensuring they reach patients worldwide.
Why You Should Apply
- Lead global regulatory strategies for innovative medical devices.
- Collaborate closely with clinical affairs and product development teams.
- Manage regulatory submissions for markets such as the US, EU, and Asia.
- Opportunity to act as a regulatory expert during technical audits.
What You’ll Be Doing
- Develop and execute regulatory strategies for new product development.
- Prepare and submit technical documentation for product approvals.
- Partner with global teams to support international registrations and renewals.
- Review marketing and labeling materials for regulatory compliance.
- Manage specific regulatory CAPAs and ensure compliance to global standards.
About You
- Be able to do the job as described.
- Proficient in FDA regulations and EU MDR requirements.
- Experience with eQMS systems and regulatory submissions (510(k), De Novo).
- Skilled in root cause analysis and CAPA management.
- Familiar with regulatory compliance in medical device manufacturing.
How To Apply
We’d love to see your resume, but we don’t need it to have a conversation. Send an email to [email protected] and tell me why you’re interested.
Or, if you do have a resume ready, apply here.
Regulatory Affairs Program Manager
As a Regulatory Affairs Program Manager, you'll play a pivotal role in guiding our medical technologies through regulatory approvals, ensuring they reach patients worldwide. Achieve global impact in regulatory affairs with a leading orthopedic company. Lead global regulatory strategies for innov...
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As a Regulatory Affairs Program Manager, you’ll play a pivotal role in guiding our medical technologies through regulatory approvals, ensuring they reach patients worldwide. Achieve global impact in regulatory affairs with a leading orthopedic company. Lead global regulatory strategies for innovativ...
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