Post Market Surveillance Clinical Specialist

Recruiter
Hologic
Location
Danbury
Salary
Competitive
Posted
Aug 13, 2017
Closes
Aug 15, 2017
Industry
Computer
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
PURPOSE AND SCOPE:

A Health Care Professional responsible for
managing the Adverse Event program and supports the Health Hazzard Evaluation
(HHE) process. This individual will receive, review, and process all product complaints
for manufactured and distributed products as required by applicable
regulations, standards, and company policy. This position combines skills in
post market regulations, statistics, and product knowledge in the process of
trending and handling incoming complaints.
Partners with Product Support, Quality Engineering, Medical Affairs and
other departments to support the overall Post Market Surveillance process.

PRINCIPAL DUTIES AND
RESPONSIBILITIES:
  • Can
    perform all the essential duties of Post Market Surveillance Specialists
  • Responsible
    for review and final decision making of escalated complaints to determine
    reportability of medical complaints
  • Facilitators
    on moderate to complex complaints with potential field action implications
  • Ensure customer communications
    are created and issued; review customer responses for technical accuracy
    related to Hologic products
  • Follow-up with the end users /
    customers for any additional information to support investigations
  • Lead
    and facilitates cross functional meetings and creates meeting minutes with
    little supervision
  • Assess medical complaints and
    assure timely decision making and reporting
  • Work with international QA/RA
    on device Vigilance complaints
  • Engage owners on determination of effective
    CAPA
  • Works
    with Medical Affairs and Engineering to perform risk assessments
  • Works
    on problems of complex and major scope where analysis of situation or data
    requires a review of a variety of factors
  • Works
    with Post Market Surveillance Specialists and Post Market Surveillance
    Engineers to ensure consistency in documenting complaints
  • Ensures
    that complaints are assessed from MDR within 3 days of receipt
  • Participate
    in external & internal audits
  • Exercises
    judgment within defined procedures and practices to determine appropriate
    action
  • Works
    with R&D to determine specific product and incident complaint codes
  • Works
    between PMSS and PMSE to ensure timely coding of completed investigations,
    closure of all complaint files, and ensures that all pertinent information
    is contained consistently and uniformly within the file prior to closure
  • Strives
    to meet Accuracy Goals (95
    accuracy goal). Ensures data is collected
    through routine business processes and reviewed for accuracy, timeliness,
    relevance, completeness, understood by users, and quality
  • Lead
    new hire training on Potential Adverse Event complaints and MDR
  • Creates
    or update QMS documents as needed
  • Reviews
    and complies with the Code of Business Conduct and all applicable company
    policies and procedures, local, state, and federal laws and regulations.
  • Assists
    with various projects as assigned.
  • Other
    duties as assigned
EDUCATION:

Bachelor's degree in medical science, heath
sciences or healthcare related field and a minimum of 3-5 years of clinical
experience.

EXPERIENCE AND REQUIRED
SKILLS:
  • Registered Nurse or CRNA or
    Registered Radiologic Technologist with related experience in the
    healthcare/device industry or exposure to medical device quality system
    regulations understanding of drug/device safety requirements are required;
    with an Advanced Degree no prior experience may be considered.
  • Experience on MDR and BPDR
    submissions (preferred)
  • Understanding
    of regulatory obligations for compliance within the scope of the
    department (21 CFR 820.198 and 21 CFR 211).
  • Prior
    experience processing medical device or drug complaints strongly
    preferred.
  • Strong
    interpersonal skills.
  • Knowledge
    based PC computer skills essential, such as industry recognized complaint
    management systems, MS Access and Excel.
Agency and Third Party Recruiter
Notice:

Agencies that submit a resume to
Hologic must have a current executed Hologic Agency Agreement executed by a
member of the Human Resource Department. In addition Agencies may only submit
candidates to positions for which they have been invited to do so by a Hologic
Recruiter. All resumes must be sent to the Hologic Recruiter under these
terms or they will not be considered.

Hologic,
Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal
Contractor

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