Senior Analyst, Product Surveillance (31019447)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
Our team in Plymouth, MN is looking for a Senior Product Surveillance Analyst
WHAT YOU’LL DO
- Communicates verbally and in writing both internally and externally regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
- Evaluates complaints/events accurately and in a timely manner
- Maintains accurate entry of complaints in database, following Good Documentation Practices (GDP).
- Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes
- Supports complaint database upgrades and conversions by providing input and performing system testing; Ensures accurate department procedures and work instructions are maintained; Support inspections by regulatory agencies (e.g. FDA, TUV) as requested.
- Additional duties of the Product Surveillance Sr. Analyst include: Coordination of improvement projects, initiatives and document updates for the department; Representation of the department on cross-functional teams; Leadership of change roll-out to the team; CAPA ownership for department investigations; Direct leadership of file management closure for the department to achieve monthly timeliness metrics; Review of complaints and Regulatory Reports to ensure compliant documentation; Support of customer communications, regulatory inquiry responses and EUMDR documentation; Maintenance of key data profiles in database; Able to lead a team of direct reports to support department growth.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other international regulatory requirements, Company policies, operating procedures, processes, and task assignments.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Four-year degree or higher in the healthcare or science fields is required. Degree in Nursing (BSN, RN, MSN) or Biomedical Engineering and knowledge of patient disease states related to structural heart is preferred.
- 5-6 years experience in Product Surveillance for medical products or equivalent with demonstrated leadership.
- Knowledge of global regulations for medical device reporting and medical terminology is a plus.
- Strong written and oral communication skills are required.
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
· A fast-paced work environment where your safety is our priority
· Production areas that are clean, well-lit and temperature-controlled
· Training and career development, with onboarding programs for new employees and tuition assistance
· Financial security through competitive compensation, incentives and retirement plans
· Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
· Paid time off
· 401(k) retirement savings with a generous company match
· The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.