Product Complaint Analyst III

Product Complaint Analyst III

Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 Additional Location(s): 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.

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, you'll 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 Men's Prosthetic Urology, Prostate Health, and Surgical Lasers. As a Product Analyst III you'll 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 Bachelor's degree Minimum of 3 years of experience in medical device complaint handling Required qualifications: Minimum of a Bachelor's degree Minimum of 3 years of experience in medical device complaint handling

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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 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 by providing a 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, neurological and urological diseases and conditions.

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.

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.