We have a current opportunity for a Senior Regulatory Affairs Specialist on a permanent basis. The position will be based in Littleton, CO. For further information about this position please apply.
Senior Regulatory Affairs Specialist
On-site - Littleton, CO
Summary:
My client is a leading additive manufacturing solutions partner committed to the innovation, performance and reliability of industry-leading surgical planning, implants, instrumentation, and medical education solutions to ultimately benefit medical device manufacturers and healthcare providers in their innovation growth. Not only does my client facilitate the cultivation of new medical device products, they also provide service to customers who lack expertise, capital, or ability to manufacture their products.
The Sr. Regulatory Affairs Specialist will take an independent active role in the preparation of submissions for regulatory approvals in various geographic regions. You will provide regulatory guidance to cross-functional partners while demonstrating strategic thinking of current and future projects.
Responsibilities:
- Demonstrated experience in multiple types of substantive regulatory filings such as 510ks, EU Technical Documentation Files, Canadian Regulatory Submissions for Class II/III devices.
- Maintain ongoing surveillance and analysis of all pertinent domestic and international medical device regulations.
- Oversee and administer reviews of product and manufacturing changes for compliance with applicable regulations.
Preferred Skills, Qualifications and Technical Proficiencies:
- Experience and understanding of regulatory landscape within 3D printed medical devices is a plus.
- Working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
- Support EU Medical Device Regulations implementation and compliance.
- Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
Preferred Education and Experience:
- Bachelor's Degree (B.S. or B.A.) required, preferably in Science, Engineering, or equivalent focus.
- 5+ years experience within Regulatory Affairs with a medical device focus.
Please reach out to Valentin Tenbrook for more information!
857-453-4071