What are the responsibilities and job description for the Product Surveillance Associate position at BayOne?
The position is fully onsite
The employee can start any time between 7am and 9am for a full 8 hour work day plus an unpaid 30 minute lunch. 40 hour minimum work week with opportunity for overtime. We will adjust start time based on team need so we don’t like to give a set start time until hired.
The Product Surveillance Associate position provides clinical and safety assessments of post-marketing events. This position is an integral role in marketing compliance with global regulations.
Work with minimal supervision and requires a high degree of interaction with customers, health care professionals and Global *** at all levels within the organization.
Processing the field inquiries received by phone, electronic or verbal correspondence in accordance to applicable SOP(s).
Provide technical support and remote troubleshooting guidance as needed.
Conduct follow up activities to be able to close records in a timely manner.
Complete investigations which may include execution of product returns and subsequent evaluations, reviews of manufacturing records, and assuring proper approvals are obtained as part of closures.
Execute the activities of processing complaints in accordance with the Company Quality System.
BS in a Physical Science or Engineering or Equivalent Experience Required
Experience in Quality Assurance and/or other regulated industry or similar experience required
Strong technical writing and general problem-solving skills required
Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)
The employee can start any time between 7am and 9am for a full 8 hour work day plus an unpaid 30 minute lunch. 40 hour minimum work week with opportunity for overtime. We will adjust start time based on team need so we don’t like to give a set start time until hired.
The Product Surveillance Associate position provides clinical and safety assessments of post-marketing events. This position is an integral role in marketing compliance with global regulations.
Work with minimal supervision and requires a high degree of interaction with customers, health care professionals and Global *** at all levels within the organization.
Processing the field inquiries received by phone, electronic or verbal correspondence in accordance to applicable SOP(s).
Provide technical support and remote troubleshooting guidance as needed.
Conduct follow up activities to be able to close records in a timely manner.
Complete investigations which may include execution of product returns and subsequent evaluations, reviews of manufacturing records, and assuring proper approvals are obtained as part of closures.
Execute the activities of processing complaints in accordance with the Company Quality System.
BS in a Physical Science or Engineering or Equivalent Experience Required
Experience in Quality Assurance and/or other regulated industry or similar experience required
Strong technical writing and general problem-solving skills required
Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)
