Bringing innovative medical device products and exciting technology to the world is an exciting and worthy endeavor. It is important for medical device companies to launch products that benefit targeted patient populations while ensuring product safety and performance. Navigating the complex and ever changing regulatory landscape is imperative to gaining product access in the United States and all relevant International markets. The Right Regulatory Affairs Talent prevents delays in the approval of pre-market submissions, prevent safety and compliance issues, mitigates additional expenses and helps to navigate upcoming changes in regulations.
Our business is people and helping our clients attract and retain the top regulatory affairs talent to support United States and international organizational strategies. If you are a company in need of the right RA talent to protect your innovative thinkers, lead with proactive regulatory strategy and help navigate the challenges of ever changing rules for compliance; SSI can help partner with you to identify and attract the top RA talent in the industry, based on your specific culture and position needs.
We have the experience, skill and resources in our Regulatory Affairs practice to meet your needs in a variety of functional areas at the VP, Director, Manager and Mid-Level:
- Class I, Class II, Class III, and Class IVD medical devices
- Combination medical devices
- PMA, PMA Supplements, 30 Day notices, IDE, etc.
- Traditional 510 (k), Special 510 (k) submissions
- De Novo submissions and Humanitarian Device Exemption
- Clinical Evaluation Reports
- International Registrations
- Technical Files, NPD Dossiers, Engineering Change Orders
- Global Regulatory Affairs Strategy
- Post-Market Quality Compliance
- MDD/MDR and EU IVDR
Our clients range from start-ups, private small businesses, mid cap companies to publicly traded and top 30 global medical device and biotech companies in the world.