Assoc MDR/Vigilance Spec - Exempt Assoc MDR/Vigilance Spec - Exempt

Location: Lafayette, CO
On site 3 days/week, core hours b/w 8am – 5 pm +/-  2hours (flexible days shift hours, but needs to be during first shift hours)

Education Required: Bachelors Degree, with a preference to science, health care or engineering degree

Top 3 things the manager is looking for: 

1. Computer skills – Microsoft Office – Outlook, Word and Excel. Including ability to read and type the English language proficiently. Experience working in a database and / or One Note preferred, but not required.

2. Attention to detail

3. Adaptable – able to fluctuate between multiple activities/tasks.

Top  Tasks or Responsibilities in scope for this role:

1. Complaint Handling Activities – May include Intake, Reportability Decisions, Regulatory Reporting, Investigation completion, Follow Up to customers/sales reps, customer letters.  May also include reviewing complaints for correctness and answering complaint related questions to internal stake holders.
2. Providing support on new process improvement projects

3.Providing audit support – May include complaint data pulls, and providing complaint records or SOPs.

Responsibilities:

Responsibilities may include the following and other duties may be assigned.

• Supports intake evaluation, processing, and communications and investigations on complaints and adverse events according to procedures and government regulations.
• Provides administrative expertise in receipt, processing and reporting of product defect complaints, serving as primary contact.
• Ensures complete and accurate records and reporting of Medical Device Reports or adverse events as required by regulatory agencies. 
• Addresses and expedites product complaints under the company's complaint policy and procedures and ensures compliance with government regulations.
• Provides technical expertise to optimize complaint processing systems.
• Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure
• Supports projects to develop or enhance programs and processes to meet regulatory reporting requirements.

While the specific roles of this position may change, the current plan is to have this person focus on complaints for our Robotic Assisted Surgery system.  Training will be provided on the documents that are received.  However, the candidate will need to be comfortable reading through and understanding some technical terminology.    

Specialist Career Stream

Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent evaluating and processing reported complaints while adhering to policies, using specialized knowledge and skills normally acquired through advanced education

Differentiating Factors:

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Shares ideas, information, status, needs and issues to inform, gain input, and support decision making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or during new employee on boarding.

Required Knowledge and Experience:

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Minimum of Bachelor’s degree with a preference to science, health care or engineering degree and 0-2 years of relevant experience.

Mut have the experience working with Microsoft Office programs (Outlook, Word and Excel).  Must be able to read and type the English language proficiently.  

Work Style:

Work style will be full time, first shift.  Will be required to be on site 2-3 days per week with the exception of time-off.  

Nice to have (preferred qualifications):

To be successful in this role, the candidate will need to be a self-starter, self-motivating, detail-oriented, able to work at a computer/desk setting, proficient in the English language, able to type proficiently, and skilled at technical writing and able to fluctuate between multiple activities/tasks.   Additionally, some experience working in data bases will be beneficial to this candidate’s success.   Some knowledge of good documentation practices (GDP), good manufacturing practices (GMP) and quality systems in a regulated environment would also be beneficial.