What are the responsibilities and job description for the Complaints Specialist position at Actalent?
What you will do:
o Under guidance, ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations.
o Initiate complaints and ensure all required information are gathered and added to the complaint file in an accurate and timely manner.
o Communicate with Customers and Shockwave Medical field reps in a timely and professional manner to gather necessary complaint information.
o Coordinate the return of complaint devices for investigation (where applicable) and collaborate with the cross-functional engineers to ensure timely investigation and risk assessment of each complaint.
o Complete adverse event reporting determinations per geography regulatory requirements for approved devices (FDA, EU MDD/MDR, PMDA, TGA etc.) and route for approval in a timely manner.
o Escalate high risk incidents to management.
o Complete MDR/ MDV reports in an accurate and timely manner and ensure they are submitted to the regulatory authorities within the required timeframe per applicable geography regulation.
o Ensure complaints are investigated and closed in a timely manner.
o Write up complaint narratives using concise and grammatically correct English which is appropriate for regulatory review.
o Support service & repair events to assess whether a complaint is warranted.
o Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint initiation, reportability assessment, MDR/ MDV Reporting, and complaint closure).
o Ensure complaints are prioritized based on the patient outcome, regulatory reporting requirements, product, and compliance risk.
o Assist with providing feedback to Customer and Shockwave Medical reps to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements.
o Ensure compliance to the Post Market Surveillance System.
o Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
o Participate in quality system activities and support internal and external audits.
o Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
o Other duties as assigned.
Requirements
o Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices is preferred.
o Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.
o Proficiency in data compilation, analysis, presentation, and document writing skills.
o Excellent written and verbal communication skills.
o The ability to understand and follow QMS Procedures (e.g., SOP and Test Methods).
o Proficient with computer-based applications (MS Word, MS Excel, QAD).
o Strong interpersonal skills and ability to provide good customer service support.
o Strong time management skills and the ability to multi-task in a fast-paced environment.
o Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Pay and Benefits
The pay range for this position is $27.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Santa Clara,CA.
Application Deadline
This position is anticipated to close on Apr 25, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $27 - $35
