Regulatory Affairs Specialist, Medical Device
- Louisville, CO
- $72,100-112,800 per year
- Permanent
- Full-time
- Coordinate and prepare document packages for regulatory submissions, audits, and inspections for both new and established products.
- Compile materials required for submissions, license renewals, and annual registrations.
- Monitor and enhance tracking and control systems to support product releases and ongoing compliance.
- Review labeling, marketing materials, and user manuals to ensure alignment with regulatory requirements.
- Recommend updates to labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
- Collaborate with cross-functional teams-including R&D, Clinical, Quality, and Marketing-participating in design reviews and developing regulatory strategies for product approvals.
- Actively support NPD projects and manage the regulatory aspects of the full design life cycle, from concept through commercialization and post-market changes.
- Help develop and refine processes, procedures, and standards to meet internal SOPs and industry regulations.
- Stay current with the latest regulations, standards, and laws impacting the medical device industry.
- 2-5 years in regulatory affairs, preferably within the medical device industry.
- Proven experience preparing regulatory documentation and supporting product release processes.
- Hands-on experience supporting New Product Development and managing the regulatory design life cycle.
- Strong written, verbal, and interpersonal communication abilities.
- Proficiency with technology applications such as MS Office.
- Knowledge of document storage systems and technical file creation.
- Understanding of ISO 13485, ISO 9001, FDA, and international regulatory requirements.
- Data and statistical analysis capabilities.
- Impeccable attention to detail.
- Regulatory Affairs Certification (RAC) and project management experience are a plus.
- Analytical mindset and sound judgment within established procedures.
- Team-oriented and able to build productive relationships across functions.
- Proactive in maintaining regulatory expertise and resolving compliance challenges.
- Dedicated to process improvement and ongoing professional growth.
- Bachelor's degree required (technical field preferred); Master's degree a plus.
- Primarily office-based work (sitting, computer use).
- Limited travel as necessary.