Senior Post Market Surveillance Analyst
Senior Post Market Surveillance Analyst
Homodeus’ mission is to empower individuals to have greater ownership of their health with rapid, low-cost home and point-of-care diagnostics. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology. We use this technology to champion a new era of personalized healthcare and help end the COVID-19 pandemic.
Homodeus is a well-funded, rapidly growing health-tech company founded by award-winning scientist and highly successful serial entrepreneur, Dr. Jonathan Rothberg. Homodeus benefits from being a 4Catalyzer company, an incubator of biotech and med device companies (most notably Butterfly Network) who have collectively raised over $700 million in funding.
Joining Homodeus is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.
The Post Market Surveillance Analyst is to collect, analyze and report complaints in compliance with national and international regulations and guidance. Monitor the performance of a medical device and trends after the release to market and ensure adverse event reports are completed and reported on time. This includes correspondence with Regulatory bodies, if applicable.
As part of our team, your core responsibilities will be:
- Knowledge of complaint handling requirements and regulations including, adverse event reporting, Health Hazard Evaluations, recalls and advisory notices
- Responsible for receiving and processing device complaints, reporting to regulatory bodies as well as Post Market Surveillance (PMS) trending and monitoring of complaints
- Implement and improve procedures and processes for complaint handling, adverse event reporting and health hazard evaluations
- Evaluate, track and complete complaints through the complaint handling process
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records
- Create and present complaint and adverse event trending information to cross-functional teams
- Facilitate the Health Hazard Management process with the cross-functional team
- Apply quality system knowledge and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits
- Maintain highly collaborative relationships with other internal groups (complaint management, product complaint investigations, clinical research, etc.)
- Generate PMS plans and reports to ensure compliance with evolving regulations
- Generate responses to Requests for Additional Information from various global regulatory authorities
- 10+ years of related experience in new product development process and resolution of quality assurance issues in biotech, medical device or pharmaceuticals industries or Bachelor's Degree in Engineering or Scientific field with 4 years experience OR Master's Degree in Engineering or Scientific field with 3 years experience in the following areas.
o Risk Management
o Bill of Materials
o Technical Documentation
- Full knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
- Full Knowledge of PLM and QMS/Customer Complaints Handling platforms such as Agile and Trackwise and their use in root cause analyses
- Must have experience in quality system audit process
- Must have Experience in end to end Customer Complaints Handling process via entry of problem record to root cause analysis to effectivity checks of preventative actions.
- Must have experience in managing Production Technical Documentation
- Must have project management experience
- Strong written and verbal communication skills
- ISO 9001/13485 knowledge, preferred
- Full knowledge and understanding of manufacturing and distribution policies, procedures, and guidelines relevant to quality compliance
- Ability to manage confidential information with discretion
- Attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Work is performed independently on complex work and reviewed for accuracy and soundness
You Deeply Identify with Core Homodeus Values:
- Efficient & Speedy - you get work done in a fraction of the time as industry peers
- Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
- Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
- Team Oriented - you celebrate and take joy in the success of others on the team
We offer great perks:
- Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
- Competitive salaried compensation - we value our employees and show it
- Equity - we want every employee to be a stakeholder
- Pre-tax commuter benefits - we make your commute more reasonable
- Free onsite meals + kitchen stocked with snacks.
- 401k plan - we facilitate your retirement goals
- Beautiful office near the ocean-front in historic Guilford, Connecticut The opportunity to build a revolutionary healthcare product and save millions of lives!
For this role, we provide visa assistance for qualified candidates.
Homodeus does not accept agency resumes.
Homodeus is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.