Employment Type: Full-time
Enlitic is shaping the next generation of diagnostic healthcare tools to help patients around the globe. Using AI and deep learning, we help Radiologists identify disease and medical issues more accurately and earlier. We believe we are addressing one of the largest social impact opportunities in healthcare with our technology deploying around the globe. Enlitic is attacking the hard, high-value challenges facing healthcare by developing solutions others are afraid to touch. We are dedicated to the development of impactful healthcare solutions. We have been featured on TED, CNN, WSJ, NY Times, Inc, Fortune, as well as named the 5th Smartest AI Company by MIT Tech Review.
● Fort Collins, Northern Colorado Area
● Relocation assistance available
● Bachelor of Arts or Bachelors of Science preferably life sciences, biomedical, or other engineering science.
● Minimum of BS degree in scientific discipline, preferably life sciences, biomedical, or other engineering science; MS or PhD a plus; auditor qualifications a plus.
● MS or PhD a plus; auditor qualifications a plus.
● 10+ years’ experience in FDA 21 CFR Part 820, ISO 13485:MDSAP, EU MDD/MDR, including successful pre-market submissions for domestic and international markets.
● Experience with 510K, Class I and Class II
● Demonstrated success related to development and implementation of pre- clinical and clinical strategies, implementation of facility regulatory and quality systems, and assuring compliance to all applicable regulations.
● Strong technical background in devices/applications. Ability to think ‘out of the box’ and create novel solutions to challenging problems is an absolute necessity.
● The successful candidate must work well in team settings and be able to work independently to ensure completion of time critical projects.
● Authoritative knowledge of current U.S. and International medical device/diagnostic regulations and guidelines.
● Excellent interpersonal and leadership skills; self-motivated and flexible to changing schedules.
● Strong attention to detail, good oral and written communication skills.
● Demonstrated record of managing collaborators and projects; demonstrated record of working on project teams and multitasking.
● Subject Matter Expert for EN ISO 13485:2016, ISO 13485: 2016, IEC 62304:2006 (including Amd 1:2015
Position Responsibilities :
● Serve as Enlitic’s Management Representative.
● Overall responsibility for leading Enlitic’s Compliance teams such as RAQA, QMS, and BMS.
● Participate as a management team member driving the growth and direction of the company, with the following responsibilities:
● Ensure that the processes specific to RAQA department are implemented, and effectively maintained. Report to executive management on the efficiency and performance of the quality system specific to RAQA objectives.
● Promote awareness of regulatory, statutory, and quality requirements throughout the organization.
● Lead efforts relating to assigned RAQA responsibilities such as EU MDR 2017/745 certification.
● Define, implement, and maintain the Product Development Life Cycle (PDLC) process.
● Support clinical and non-clinical strategies by providing RAQA guidance to the Clinical Team as it relates to demonstration of product intended use and performance.
● Manage the preparation and submission of required documentation (510(k)s, PMAs, Design Dossiers, etc.) to regulatory agencies U.S. FDA to obtain clearance and/or approval.
● Organize efforts and serve as key contact in support facility inspections by regulatory agencies such as FDA and Notified Bodies.
● Provide regulatory affairs and quality assurance guidance to all functional organizations, while collaborating closely with other Executive Management Team Members to define the strategic direction of the organization to drive business growth.
● Develop and implement strategies to assist in educating appropriate regulatory agencies, when requested on various aspects of the technology and scientific principles upon which medical technologies operate.
● Oversee and assist in the review and approvals of product packaging, labeling and Marketing materials.
● Identify and ensure compliance to relevant standards for product development, including appropriate design requirements for domestic and international markets. This includes, but is not limited to IEC 62304, FDA Part 820, and ISO 13485:2016 (MDSAP).
● Ensure the company is in full compliance with appropriate global regulations, including notifications regarding significant changes to the product. Develop Regulatory Assessments for new and revised product.
● Promote the development of a facility-wide understanding of the key elements related to regulatory and quality compliance requirements.
● Maintenance of the quality system and associated training that is required.
● Effectively lead and manage department regulatory and quality personnel.
● Understand and practice all requirements of EN ISO 13485:2016, ISO 13485:2016, QMS Manual, Process Flows and Work Instructions.
● Comply with applicable regulatory requirements (including but not limited to MDSAP participating countries and CE Marking)
● Participate in Internal and External audits.
Our people love working here because they are challenged by unique and difficult problems in a nimble startup environment that is backed by five plus years of success in performance.
-Health, vision, and dental insurance
-Company paid Short Term Disability
-Company paid Long Term Disability
-Company paid employee Life Insurance
-Up to 10% 401k match
-$180 a month health and fitness stipend