Senior Regulatory Affairs Specialist
Enovis
Senior Regulatory Affairs Specialist
Enovis is seeking a Senior Regulatory Affairs Specialist to develop and execute regulatory strategies for medical devices, including hardware and software as a medical device (SaMD), in the orthopedic industry. The role involves managing regulatory activities in the US, EU, and Australia, ensuring compliance with TGA, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820. The ideal candidate has 5+ years of experience in medical devices and proven skills in preparing regulatory submissions.
Senior Regulatory Affairs Specialist
Enovis is seeking a Senior Regulatory Affairs Specialist to develop and execute regulatory strategies for medical devices, including hardware and software as a medical device (SaMD), in the orthopedic industry. The role involves managing regulatory activities in the US, EU, and Australia, ensuring compliance with TGA, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820. The ideal candidate has 5+ years of experience in medical devices and proven skills in preparing regulatory submissions.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Develop global regulatory strategies for new product development initiatives
- Lead pre-submission meetings with FDA, Notified Body, and TGA
- Partner with clinical affairs in development and execution of clinical strategy
- Act as regulatory representative on product development teams
- Prepare submissions and technical documentation for product approvals in the US, EU, and Australia
- Partner with Corporate Market Access team to coordinate international registrations
- Act as regulatory SME during technical documentation audits
- Perform regulatory assessments on product or process changes
- Review and approve QMS change orders, design change orders, and NCRs
- Review labeling and marketing collateral for compliance
- Own and manage regulatory-related CAPAs
- Support completion of HHEs and manage field actions and recalls
- Monitor industry-applicable regulations and standards
- Maintain regulatory metrics for reporting to management
- Participate in review of engineering specifications and quality programs
- Partner with Sales, Operations, and other functions to provide QA/RA guidance
- Review marketing, training, and educational materials for compliance
- Work with cross-functional teams to ensure regulatory and quality requirements
- Align local RA activities with global policies and standards