Post Market Surveillance Specialist
Post Market Surveillance Specialist
Posted on :
21-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Yearly Salary
$ 93000 - 110000
Vacancy
1 Vacancy
Posted on :
21-04-2025
Job Description
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows we improve the quality of life of patients provide more effective treatment options for surgeons uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:
Do you want to be part of an innovative cuttingedge technology robotics company that is changing how BPH is treated Are you looking to be part of an enthusiastic driven passionate and challenging team who continuously learn from one another Are you detailedoriented At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Post Market Surveillance Team. You will work with crossfunctional teams to maintain and improve the complaint handling and Post Market Surveillance functions within the requirements of FDAs Quality System Regulation (QSR) ISO 13485 (ISO) MDSAP EU MDR and NMPA. Being detail and solutionoriented proactive and selfmanaged will assist in the success of this position.
What Your DayToDay Will Involve:
- Support the maintenance and continuous improvements of the Post Market Surveillance (PMS) system.
- Assure timely complaint initiation investigation/analysis reportability assessments and reporting to appropriate domestic as well as international governments and complaint closures.
- Evaluate documentation for completeness and consistency and execute additional actions as necessary to close the complaint file.
- Perform Good Faith Efforts for product return and to obtain required information for complaint assessment and evaluation.
- Collaborate with medical affairs customer service global sales team professional educators and clinical specialists to obtain accurate complaint information.
- Complete adverse event reporting determinations per geography regulatory requirements for approved devices (US FDA EU MDD/MDR Health Canada PMDA China etc. in a timely manner.
- Complete adverse event reports in an accurate and timely manner and ensure these are submitted to the regulatory authorities within the required timeframe per applicable geography regulations.
- Review analyze interpret and summarize PMS data; draw conclusions and make appropriate recommendations and decisions.
- Recognize complaint trends potential product problems and potential recalls and initiate immediate remedial action if appropriate.
- Prepare reports for management reviews monthly complaint trend meetings and other required reports as requested.
- Work closely with the Design Quality Engineering team to update Risk Management files when new failure modes or new frequency of occurrence are identified.
- Interfaces directly with internal and external customers and regulatory agencies as required.
- Support PMS reporting activities such as PMS plans PMS reports (PMSR) and/or period update safety reports (PSUR) for PROCEPT BioRobotics devices.
- Prepare responses to customer requests for failure analysis results as required.
- Participate and support internal and external audits as needed.
- Maintain trained status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
- Understand and adhere to the PROCEPT BioRobotics EHS policy.
The Qualifications We Need You to Possess
- Bachelors degree or a combination of education and experience providing equivalent knowledge.
- 2 years of complaint handling experience and/or postmarket surveillance in the medical device or a regulated industry.
- Working knowledge and experience with US FDA 21 CFR 803 Medical Device Reporting US FDA 21 CFR 820 ISO 13485 MDSAP EU MDR/MDD vigilance reporting requirements PMDA China.
The Qualifications We Would Like You to Possess
- Working knowledge and experience with US FDA 21 CFR 803 Medical Device Reporting US FDA 21 CFR 820 ISO 13485 MDSAP EU MDR/MDD vigilance reporting requirements PMDA.
- Ability to work in a fastpaced environment with multiple tasks/projects.
- Excellent prioritizing organizational and interpersonal skills.
- A detailoriented individual with a can do attitude and the ability to work in a team environment as well as individually (with minimal supervision).
- Hybrid schedule
For USBased Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role the anticipated base pay range is $per year.
Plus eligibility for an annual bonus and equity/RSUs
Understanding PROCEPTs Culture
At PROCEPT we believe every person matters. Every employee every patient every caregiver. Because we are here to create a revolution and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do while also working together seamlessly for a common goal. At Procept curiosity ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesnt happen by accident. It starts with our live induction program that serves as an incubator for crossfunctional team building an immersion in Procepts history jampacked interactive sessions with executive leadership and a crashcourse in the mission and purpose of what we do. It continues with our oneofakind management program designed to build the best managers in the industry where our people managers across functions come together to exchange ideas and grow as both managers and learners in an environment that challenges supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept we push beyond just finding a work/life balance we strive to find a work/life blend a professional world that you are honored and impassioned to belong to one that you can proudly share with your family friends and acquaintances.
An opportunity at PROCEPT BioRobotics wont just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
BENEFITS OF WORKING AT PROCEPT!
PROCEPTs health and wellness benefits for employees are second to none in the industry. As an organization one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage wellness programs onsite gym a 401(k) plan with employer match shortterm and longterm disability coverage basic life insurance wellbeing benefits flexible or paid time off paid parental leave paid holidays and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race color national origin religion gender gender identity sexual orientation disability genetic information pregnancy age or any other protected status set forth in federal state or local laws. This policy applies to all employment practices within our organization.
PAY RANGE TRANSPARENCY
Procept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for noncommissionable roles or ontarget earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to jobrelated skills depth of experience relevant certifications and training and specific work location. Based on the factors above Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus equity and the benefits listed above.
WORK ENVIRONMENT
Well provide you training for and ask you to maintain trained status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
