Location: Fort Collins
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.
-Fort Collins, Northern Colorado Area.
-Bachelor of Science and/or relevant healthcare/medical device industry work experience
-3+ years of experience working in a regulated medical industry, preferably in regulatory affairs or an associated discipline.
-Working knowledge of ISO 13485: MDSAP and medical device regulations such as FDA 21 Part 820 and EU Medical Device Regulations 2017/745, including device classification and pre-market submission requirements.
-Working knowledge of market requirements for other MDSAP participating territories is a plus.
-Experience preparing submissions and/or technical documentation for review by international regulatory authorities or organizations, such as Notified Bodies.
-Experience interacting with regulatory agencies and/or Notified Bodies related to submissions, audit and/or inspection.
-Strong attention to detail, good oral and written communication skills.
-Ability to work independently, as well as coordinate cross-functional team activities such as documentation drafting and review.
-Ability to think ‘out of the box’ and create novel solutions to challenging problems is an absolute necessity.
-Strong technical background in devices/applications and familiarity with Software-as-a-Medical-Device and/or radiology/medical imaging is a plus.
-Experience with QMS, and standards such as IEC 62304 and ISO 14971 is an asset.
-Serve as a regulatory representative on cross-functional product teams, and advise on product development, particularly around commercialization strategies for international target markets.
-Identify relevant quality standards and regulatory requirements for product development and commercialization, including appropriate design and documentation requirements for target international markets.
-When needed, provide support in performing regulatory assessment and device classification in relevant territories.
-Contribute to the development and maintenance of QMS documentation compliant with relevant international standards and requirements.
-Identify pre-market submission requirements for medical device products in target international markets.
-Support the development of submissions to international regulatory authorities, and co-author documents included in these submissions, as needed.
-Identify approximate timelines associated with international regulatory certifications and submission reviews, and ensure relevant stakeholders are informed in order to effectively manage business expectations.
-Oversee/coordinate the translation of product labeling and other relevant documentation according to applicable regional/regulatory requirements, as needed.
-Oversee/support in the review and approvals of product labeling and marketing materials, particularly those intended for distribution in international markets.
-Support preparations for and participate in both internal and external audits.
-Attend meetings with regulatory agencies and notified bodies, as needed.
-Support efforts to promote company-wide/internal training and understanding of international RAQA compliance requirements.
-Identify requirements associated with, and support the execution of, PMS activities for products marketed in relevant international territories.
ISO/BMS Responsibilities :
-Understand and practice all requirements of EN ISO 13485:2016, Enlitic’s Quality Manual and associated QMS policies, procedures, and work instructions.
-Comply with applicable regulatory requirements (including but not limited to MDSAP participating countries and EU MDR).
-Participate in Internal and External audits. -Assist with the writing and development of relevant SOPs
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
-Annual Salary Range: $60K to $80K depending on experience