Lead Post Market Surveillance Specialist
Campbell, CA
Full Time
Quality
Experienced
Title: Lead Post Market Surveillance Specialist
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
An individual in this role uses advanced expertise to oversee activities for monitoring the Complaints and Post Market Surveillance System, conducting complaint intake activities, assessing regulatory reporting, leading complaint investigations, submitting regulatory reports, maintaining quality compliance, and achieving quality metrics in areas of responsibility. This position will collaborate directly with customers, Regulatory Agencies, Notified Bodies, and requires extensive knowledge of industry practices, techniques, and standards.
- Ensure compliance of the Complaints System to internal requirements and applicable Regulations.
- Establish and report on complaint trends with actions for resolution.
- Review adverse event reporting determinations against applicable regulatory requirements (FDA, EU MDD/MDR, PMDA, TGA etc.).
- Complete reportability assessment and route for approvals in a timely manner.
- Accurately assess risk and escalate high risk incidents to appropriate management.
- Complete and submit applicable regulatory reporting documents in an accurate and timely manner.
- Determine if an investigation is necessary. Support investigation activities as necessary for complaints processing/closure in a uniform and timely manner. Determine potential cause and contributing factors to the alleged event, device relationship, and whether formal device investigation is necessary.
- Conduct complaint investigations using concise and grammatically correct language appropriate for regulatory review.
- Develop, maintain, and improve procedures for device failure analysis.
- Perform timely, methodical failure analyses of devices, including failure replication to determine cause of device failure.
- Ensure complaints are closed in a timely manner and in compliance with FDA and other regulatory requirements
- Ensure complaints are prioritized based on patient, product, and compliance risk.
- Communicate with Customers and field reps in a professional manner to gather complaint information.
- Assist with training Customers and field reps to ensure compliance to Post Market Surveillance requirements.
- Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch in the required/applicable? geographies.
- Develop and implement complaint event tracking and trending data collection tools.
- Work cross-functionally to compile and generate periodic reports in a timely manner to support Post Market Surveillance activities.
- On an ongoing basis, monitor adequacy of the Complaints, Post Market Surveillance and Recalls System, and identify and implement system improvements.
- Draft new procedures and system changes as needed to accommodate regulatory requirements for new country introductions.
- Ensure the Post Market Surveillance Systems are tied to Risk Management process
- Support Regulatory submissions by providing Post Market Surveillance data trends.
What You’ll Bring – minimum requirements for this role:
Bachelor’s degree in nursing or related discipline and a minimum of 8 years of progressive responsibility in Medical Device Complaint handling of Class II/III devices; or equivalent combination of education and work experience.
- Ability to be self-directed, receive general instructions.
- Experience working with test instruments and tools such as microscopes, measuring equipment, borescopes, etc as part of device analysis
- Proficiency in data compilation, analysis, presentation, communication and document writing skills.
- Working knowledge of cGMP, Medical Device Reporting, FDA 820 QMSR and ISO 13485 or other Quality Systems.
- Proficiency with computer-based applications (MS Word, MS Excel, QAD).
- Strong time management skills and the ability to multi-task in a fast-paced environment.
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.
- Effective interpersonal skills to communicate with internal and external customers including physicians, hospital staff, and regulatory agencies.
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Imperative Care
Salary Range: $116,000 – 127,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.
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