Telluride Medical Partners is an actively growing company, continuously in search of innovative and talented professionals. If you are interested in working for Telluride Medical Partners and your position of interest is not currently listed, we encourage you to submit your resume via the form below for our data base. Note all resumes and position inquiries are kept confidential.
Regulatory Affairs Manager
Sept. 1 2017
Early-stage medical device startups
Open for immediate consideration is the role of Regulatory Affairs Manager, with the ability to move into a Director level. This fast growing company is looking for professionals that have the ability to perform and own regulatory activities associated with compliance and commercialization for medical devices globally.
The Regulatory Affairs Manager is responsible for strategizing and satisfying regulation requirements for commercialization globally and for ensuring that we remain compliant in those markets post launch.
- Developing regulatory plans to obtain regulatory clearance to market in the US, EU and other countries
- Execute on the established plans in writing, formulating, compiling and organizing all communications and documentations necessary to achieve clearances
- Work with engineers to determine testing and regulation standards that must be adhered to as the product is nearing commercialization
- Support the quality department in ensuring that the company’s standard operating procedures meet the necessary regulations and that they are being followed
- Develop SOPs, processes and work instructions that comply to regulations
- Be the internal regulatory strategist in terms of strategizing for business development plans and budgets
- Prepare and manage device labeling to ensure accuracy and compliance to standards
- Work with contract manufacturers as our internal regulatory point person in supplying TMP direction and support
- Fill in where appropriate for quality management or document control matters
- Plan and execute regulatory submissions necessary for clinical studies
- Support the clinical team in developing clinical studies that will support regulatory requirements and submissions
- 5+ years in regulatory
- Ability to establish and communicate strategic plans, timelines and budgets including defining requirements necessary for a successful commercialization globally
- Personally have written, submitted and received clearance through 510k submissions
- Personally have written, submitted and received clearance for CE mark
- Experience with additional OUS regulatory agencies in order to formulate strategic launch plans and timelines.
- Extensive knowledge of regulatory requirements to direct internal activities strategically and to maintain compliance
- Worked in an entrepreneurial startup environment
- High functioning collaborator
- Shown an ability to execute with or without significant resources
For further information please contact:
SVP, Telluride Medical Partners, LLC
About Telluride Medical Partners
Telluride Medical Partners is a boutique investment and incubation group focused on founding, fixing and/or scaling medical device startups. This is done by utilizing internal expertise, funds, resources, connections to advance high
return-capable companies forward.