Product Complaint Analyst II

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 60,000 - 114,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Product Complaint Analyst II to analyze customer complaints for regulatory reportability within the Urology portfolio and coordinate with internal teams, field staff, and end users. The role requires adherence to CFR regulations and involves preparing regulatory reports and communications.

The position follows a hybrid work model requiring attendance in the local office at least three days per week, with relocation not available.

Qualifications

• Bachelor’s degree or equivalent education is required.
• 1+ years of experience in medical device complaint processing & reporting is required.
• Excellent written and verbal communication skills are essential.

Responsibilities

• Review complaint communications and assess complaints for regulatory reportability and impact on patient safety and business operations.
• Gather data from clinical staff, field representatives, internal employees, and labs to investigate complaints.
• Determine regulatory reportability decisions using event investigation models and regulatory standards.
• Contribute to development and modification of decision models for product advances and therapies.
• Write Medical Device Reports (MDRs) and other regulatory reports and ensure timely submission to authorities.
• Apply proper coding to events and review investigations with engineering and lab teams.
• Prepare clear written communications detailing observations and actions for physicians and end users.

Skills

Communication skills

Time management

Critical thinking

Education

Bachelor’s degree or equivalent education

Job description

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Additional Location(s): US-MN-Arden Hills; US-CA-Irvine; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

The Product Complaint Analyst II will work in a fast-paced environment to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable and will coordinate activities with internal, field, and end use customers. The focus of this role will be products within the Urology portfolio. and the Product Complaint Analyst II will be responsible for adhering to proper complaint handling procedures per the Code of Federal Registration (CFR) and other governmental regulations. The Product Complaint Analyst II will communicates event investigation results via regulatory reports and other written communication, as appropriate and applicable.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Review complaint communications and assess complaints for regulatory reportability, and potential impacts to patient safety and business operations.
• Apply clinical knowledge, as related to product usage, to evaluate complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, laboratory analysis results, and other relevant sources.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
• Write Medical Device Reports (MDRs), Vigilance, and other regulatory reports, ensuring timely submission to the appropriate regulatory authorities.
• Accurately and consistently apply codes to events. Review coding and investigations with engineering, laboratory, and other internal staff, as appropriate.
• Effectively compose written communication, detailing the clinical observations, investigations and/or product analyses and corrective actions, as applicable, to physicians and other end use customers.

Required qualifications:

• Bachelor’s degree or equivalent education
• 1+ years of experience in medical device complaint processing & reporting
• Excellent written and verbal communication skills are essential

Preferred qualifications:

• Self-motivated, goal-driven and results-oriented team player
• Critical thinking and good time management skills
• College Degree focus in Biology, Health Sciences, Biotechnology or Engineeringpreferred

Requisition ID:633319

Minimum Salary:$59900

Maximum Salary: $113800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market: Minneapolis
Job Segment: Urology, Compliance, Scientific, Laboratory, Law, Healthcare, Legal, Engineering, Science