Job Description Summary Job Description The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities along with supporting all other geographical regions registrations. In addition, this position will help support RA management with guidance and mentoring of department employees. ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned. Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents). Prepare and support 510(k), IDE, PMA and Design Dossier submissions as required. Prepare technical files for CE marking activities and notified body interaction as required. Provide regulatory support and guidance for post market activities including remedial actions, labeling and advertising and promotional material....
Oct 30, 2020
Job Description Summary Job Description The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities along with supporting all other geographical regions registrations. In addition, this position will help support RA management with guidance and mentoring of department employees. ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned. Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents). Prepare and support 510(k), IDE, PMA and Design Dossier submissions as required. Prepare technical files for CE marking activities and notified body interaction as required. Provide regulatory support and guidance for post market activities including remedial actions, labeling and advertising and promotional material....
Ignite Mental Health
Remote * (Covington, KY, USA)
Do you want to improve the world? Have you ever wondered what it would be like to learn and grow at a world-changing organization just as they started growing rapidly? Excited by the opportunity to power world-class entrepreneurs and Changemakers as they work to positively impact the lives of 100,000's & 1,000,000's? At Ignite Mental Health we're accelerating world-class mental health entrepreneurs and mobilizing key change agents to catalyze the scalable innovations and legislative changes needed to transform the future of student mental health literacy and access. Using this approach, we're working to make the impossible inevitable; helping build and scale lasting legislative changes and breakthrough organizations to be as impactful as Google and Facebook that focus solely on equipping every student with a standard measure of mental health literacy and access. All of us at Ignite have experienced first-hand, or through that of loved ones and friends, the pain caused by how...
Oct 30, 2020
Part-Time
Do you want to improve the world? Have you ever wondered what it would be like to learn and grow at a world-changing organization just as they started growing rapidly? Excited by the opportunity to power world-class entrepreneurs and Changemakers as they work to positively impact the lives of 100,000's & 1,000,000's? At Ignite Mental Health we're accelerating world-class mental health entrepreneurs and mobilizing key change agents to catalyze the scalable innovations and legislative changes needed to transform the future of student mental health literacy and access. Using this approach, we're working to make the impossible inevitable; helping build and scale lasting legislative changes and breakthrough organizations to be as impactful as Google and Facebook that focus solely on equipping every student with a standard measure of mental health literacy and access. All of us at Ignite have experienced first-hand, or through that of loved ones and friends, the pain caused by how...
Ignite Mental Health
Remote * (Covington, KY, USA)
** It would be appreciated if all emails/communications were directed to Ignite & not the Harvard Innovation Lab, Harvard Business School or Harvard University. Do you want to improve the world? Have you ever wondered what it would be like to join a driven, tight-knit community of highly talented peers at a world-changing organization just as they started growing rapidly? Excited by the opportunity to power world-class entrepreneurs and Changemakers as they work to positively impact the lives of 1,000's, 100,000's or 1,000,000's? At Ignite Mental Health we're accelerating world-class mental health entrepreneurs and mobilizing key change agents to catalyze the scalable innovations and legislative changes needed to transform the future of student mental health literacy and access. Using this approach, we're working to make the impossible inevitable; helping build and scale lasting legislative changes and breakthrough organizations to be as impactful as Google and Facebook that...
Oct 30, 2020
Part-Time
** It would be appreciated if all emails/communications were directed to Ignite & not the Harvard Innovation Lab, Harvard Business School or Harvard University. Do you want to improve the world? Have you ever wondered what it would be like to join a driven, tight-knit community of highly talented peers at a world-changing organization just as they started growing rapidly? Excited by the opportunity to power world-class entrepreneurs and Changemakers as they work to positively impact the lives of 1,000's, 100,000's or 1,000,000's? At Ignite Mental Health we're accelerating world-class mental health entrepreneurs and mobilizing key change agents to catalyze the scalable innovations and legislative changes needed to transform the future of student mental health literacy and access. Using this approach, we're working to make the impossible inevitable; helping build and scale lasting legislative changes and breakthrough organizations to be as impactful as Google and Facebook that...
