Senior Global Regulatory Specialist

July 18

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Eko Health

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Eko Health is a leader in AI technology for heart and lung disease detection. Early Detection is Primary.

artificial intelligence • machine learning • digital health • telehealth • telemedicine

51 - 200

Description

• Assist/lead global regulatory submissions and build regulatory guidance and strategy • Assist/lead creation of technical files and global internal and external submission documents • Represent Regulatory Affairs on assigned project teams through all phases of product life cycle, including but not limited to design reviews, risk file reviews, V&V reviews, post-market surveillance review • Lead and assess regulatory implications of the change management process internally and change management notifications and amendment submissions globally • Assist with regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time • Work with internal and external partners on planning and execution of projects and help with timely communication with external partners and present the company in meetings • Assist/Oversee compilation, electronic processing, and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements • Oversee the maintenance and creation of relevant SOPs, Work Instructions, and other necessary guidance • Assist with US FDA, EU MDR and UKCA submissions, maintenance, and post-market activities

Requirements

• Bachelor or higher degree in a scientific field required • 5+ years of experience in Regulatory/Global Regulatory Affairs for medical devices, and/or software as a medical device and digital health • Successful track record of filing Marketing Applications • Must have strong regulatory experience and knowledge with US and EU (MDD/MDR) • Strong interpersonal verbal, written and presentation skills in communication with internal and external parties • Must be comfortable working for a small organization, and able to handle ambiguity

Benefits

• Paid-time off • Medical/Dental/Vision, Disability + Life Insurance • One Medical membership • Parental Leave • 401k Matching • Work from home equipment stipend • Flexible schedules • Wellness programs (Wellness Wednesdays, Time off) • Wellness perks (Headspace, Ginger, Aaptiv, Physera) • Learning and Development stipend