Sr. Regulatory Affairs Consultant
EPM Scientific is supporting a Global MedTech to hire a Sr. RA Consultant to join their Joint Replacement RA Team, looking for someone with a strong background in EU & US regulations, ideally with Orthopaedics & Sustaining/Change Control experience.
This is a 12 month, 4 days per week, remote hourly rate contract, start dates ideally mid-September.
Job Description:
- Support development and execution of regulatory strategies using Regulatory intelligence.
- Provide regulatory guidance across the product lifecycle to ensure compliance from concept through commercialization.
- Evaluate regulatory classifications, submission pathways, market access requirements, and approval strategies.
- Anticipate regulatory risks, identify obstacles, and develop solutions for product development, manufacturing, clinical, and commercial activities.
- Advise cross-functional teams on global regulatory requirements, including QA, (pre)clinical, labeling, and product claims.
- Assess quality and (pre)clinical documentation to support submissions and ensure compliance with applicable regulations.
- Evaluate product, manufacturing, and (pre)clinical changes and determine appropriate regulatory filing strategies.
- Prepare, submit, and manage regulatory submissions and communications with health authorities throughout review and approval processes.
- Represent RA in agency interactions, inspections, advisory committees, and panel meetings, including negotiation with authorities where required.
- Develop, implement, and maintain regulatory procedures and SOPs, while supporting compliance initiatives across departments.
- Train and advise stakeholders on regulatory requirements and emerging regulations to ensure ongoing organizational compliance.
Interviews will take place the W/C 7th September, apply now for immediate consideration.
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