Regulatory Technical Specialist
Business Unit: Ultrasound
Requisition Number: 227005
Primary Location: United States-Washington-Issaquah
Other Locations: United States-California-Mountain View
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 20%
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
This position reports to the Director of Regulatory Affairs & Compliance and has responsibility for a broad range of regulatory issues with primary responsibility for submission of 510(k) notifications and international regulatory filings. The position requires skills in interacting with Global Siemens Regional units to drive efficient country registrations. This role will also work on new product development projects as a critical team member, guiding the product teams to develop effective regulatory strategies, as well as ensuring that during the design phase documentation (DHFs) meet existing domestic and international requirements.
-Work with product development teams to develop regulatory filing strategies and define submission deliverables
-Work with marketing and sales department to ensure compliance with labeling and promotional regulations and guidelines
-Serve as a subject matter expert and resource to respond to inquiries from the development teams and other stakeholders related to regulatory requirements and submissions for FDA and other countries with existing or emerging regulations.
-Work with global Regional Units to develop processes for expediting country registrations
-Ensure that all documents and files are submitted for all regulatory applications.
-Assure data provided to regulatory agencies to prove that the new product or modification is safe and effective (by design).
-Work with business partners on joint regulatory projects
-Assist in review of product labeling and promotional issues
-Participate in quality system internal and external audits
-Stay current with submission regulations, quality standards/systems for all company products and markets
Required Knowledge/Skills, Education, and Experience:
-BA/BS required; graduate degree preferred
-10 years experience working in Regulatory Compliance in a medical device industry mandatory.
Extensive knowledge and experience in US and International medical device issues
-Experience with FDA QSR and ISO13485 requirements and experience in FDA and quality system implementation.
-Demonstrated experience in the following areas: interacting and negotiating with maintain quality systems; participating in quality systems audits (internal and external); responding to audit issues; performing continuous improvement of the quality system; assisting with the coordination of external audits from regulatory authorities
- Solid working knowledge of FDA and international medical device regulations
-Ability to perform in a fast paced and demanding environment
Ability to work effectively in a fast passed rapidly changing environment
Available to travel 25-30% time
Preferred Knowledge/Skills, Education, and Experience:
-Graduate degree and training preferred
-Auditor certificate preferred