Product Complaint Analyst II

Boston Scientific; Marlborough (MA); Hybrid; USD 61,000 - 115,900; Full time

Job summary

A leading medical technology corporation is looking for a Product Complaint Analyst II in Marlborough, MA. This role involves reviewing product quality complaints, ensuring compliance with regulations, and authoring critical reports. Ideal candidates will have a bachelor's degree and at least one year of relevant experience. The position follows a hybrid work model, requiring in-office presence three times a week. The company offers competitive compensation, ranging from $61,000 to $115,900 based on experience and qualifications.

Qualifications

• Minimum of 1 year of related experience required.
• Strong understanding of complaint handling procedures.
• Familiarity with medical device regulations preferred.

Responsibilities

• Review complaint communications for regulatory compliance.
• Investigate complaints by gathering data from various sources.
• Author Medical Device Reports and ensure timely submission.

Skills

Analytical skills

Clinical knowledge

Regulatory compliance

Education

Bachelors degree

Job description

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 provides technical, reporting and analytical support expertise in reviewing product quality complaints, serving as primary contact. Monitors complaint information and provides suggestions to appropriate company authorities as to where improvement opportunities exist based upon patterns and related analyses. Provides technical expertise to optimize complaint analysis strategies and systems. Monitors systems and data to facilitate the appropriate and timely handling of all product complaints per the company’s compliant handling procedure. Ensures compliance with applicable regulations, company policies and procedures. 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.

Responsibilities

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Author Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.

Required Qualifications

• Bachelors degree
• Minimum of 1 year of related experience

Preferred Qualifications

• Previous Complaint Handling experience
• Knowledge of medical devices and associated regulations
• Post market surveillance experience or knowledge.

Requisition ID: 620527
Minimum Salary: $61,000
Maximum Salary: $115,900

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.

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 U.S. 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 specific prohibited substance test 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.