Senior Regulatory Affairs Associate

Local candidates preferred and some remote may be possibleThe Senior Regulatory Affairs Associate is responsible for submitting required documentation to and communicating with regulatory authorities in order to meet the applicable requirements to ship commercial product to a given geography. This role is also responsible for appropriate documentation and communication to sustain the above regulatory requirements.

• Provides guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
• Submits required documentation to and communicating with regulatory authorities in order to meet applicable requirements to ship commercial product to a given geography
• Maintains appropriate documentation and communication to sustain the above regulatory requirements
• Provides leadership and delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals
• Develops and documents regulatory strategies for product submissions
• Leads, facilitates and prepares U.S., EU, and other applicable regulatory submission documents
• Prepares regulatory submissions, (eg: US: PMA, PMA supplement, 510(k); EU: Design Dossiers; and as applicable for other geographies)
• Perform regulatory assessment of new and changed products
• Keeps abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Develops and conducts trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment
• Leads regulatory department in the update, enhancement, and creation of internal policies and procedures

• Minimum of 7 years of regulatory affairs experience in a similar or equivalent role
• Bachelors degree in engineering, science, or related disciplines; Masters degree preferred
• Medical device experience, particularly neuromodulation preferred
• Experience with communicating with Regulatory Authorities verbally and orally