Product Complaint Analyst III

Additional Location(s):US-MA-Marlborough; US-MN-Maple Grove

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

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:

The Product Analyst III operates in a fast-paced evolving and dynamic environment analyzing customer feedback to support complaint determination. This role utilizes Hazard Analysis (HA) and Design Failure Mode and Effects Analysis (DFMEA) to review and process Complaint Management Center (CMC) decision rationale statements. The Product Analyst III performs good faith efforts and coordinates activities with internal teams field personnel and end-use customers.

As a Product Analyst III youll write Medical Device Reports (MDR) and Medical Device Vigilance (MDV) regulatory submissions for the Urology Complaint Management Center (CMC). Additionally you will communicate event investigation results through regulatory reports and other written communications as appropriate. Products within scope include Mens Prosthetic Urology Prostate Health and Surgical Lasers. As a Product Analyst III youll ensure compliance with Good Manufacturing Practices (GMPs) divisional Standard Operating Procedures (SOPs) Work Instructions (WIs) and proper complaint handling in accordance with 21 CFR Part 820 EU MDR MDSAP ISO 13485 and other applicable regulatory requirements.

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:

• Will perform thorough review of regulatory assessment MDR/MDV and will provide complaint owners with feedback per CMC SOPs and WI.
• 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 HA DFMEA reported 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.
• Compose written communications detailing the clinical observation investigation and/or product analysis and corrective actions as applicable to physician and other end use customers.
• Collaborate on new ideas and when needed participate in divisional improvement projects.
• Provide support in the following areas: subject matter experts for divisional products audit readiness NCEP/CAPA investigation and ownership.
• Collaborate on new ideas and when needed participate in divisional improvement projects.

Required qualifications:

• Minimum of a Bachelors degree
• Minimum of 3 years of experience in medical device complaint handling

Preferred qualifications:

• Excellent written and verbal communication critical thinking and time management skills
• Prior complaint handling experience for urological or laser devices
• Proficiency in a second language
• Proficiency with SAS PowerBI or TrackWise applications
• Experienced working collaboratively with cross-functional and global partners

Requisition ID:625888

Minimum Salary:$65800

Maximum Salary: $125000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see 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 oncologicalneurologicaland urological diseases and conditions. Learn more atand follow us onLinkedIn.

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 Companys 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.