Associate Product Complaint Manager

Additional Location(s): N/A\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s 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\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions. \n\nAbout the role: This role is responsible for managing the Post Market Surveillance (PMS) staff and overseeing compliance activities associated with Boston Scientific\u2019s complaint handling program, in alignment with corporate, domestic, and international regulations. This includes ensuring compliance with CFR Part 820 and 803, and other applicable global regulatory requirements.\n\nThe Associate Manager serves as a quality liaison across business units, both internally and externally, with responsibility for risk management and complaint handling processes. This individual plays a critical role in driving patients\u2019 safety and product quality, while demonstrating a consistent commitment to Boston Scientific\u2019s Quality Policy and documented procedures. This position reports to the Manager, Product Complaint.\n\nThis role follows a hybrid work model requiring employees to be in our Arden Hills, MN office at least three days per week.\n\n \nBoston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.\n\nThis role will not provide relocation support or assistance.\n\nYour responsibilities will include: \n\n * Escalate and participate in resolution of potential product deficiencies for all applicable BSC products.\n * Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards.\n\n\n * Consistent, positive influence on the culture of the team, setting an example as a leader of high-quality work, effective communication, dealing with adversity, and solution-oriented thinking.\n * Manages performance and professional growth and development of staff\n * Monitors daily work operations to achieve company, division and project goals by providing direction and guidance to staff and empowering them to do their best work\n * Maintain processes and procedures for ensuring compliance to corporate policies as well as external regulations and standards\n * Understanding and ensuring compliance to US \u0026 OUS regulatory requirements for medical devices for complaint handling and regulatory reporting\n * Participating in the Global Quality Community to improve post market quality across multiple divisions.\n * Coordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelines\n * Provide clear communication on deliverables, timelines and milestones\n * Influence change and align stakeholders to make decisions with limited information\n * Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures\n * Coordinates and participates in escalation of adverse complaint trends or product issues\n * Ensure appropriate training is provided to the Post Market Surveillance staff\n * Recommend staffing or other necessary resources in order to achieve business goals and compliance requirements\n * Oversee the accuracy, completeness, and maintenance of the complaint records as it is documented in Global Complaint Management Database\n * Stay updated of the internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports\n\n\n\nRequired qualifications: \n\n * Minimum of 5 years of medical device industry, pharmaceutical, or diagnostic device experience\n * Proven people leadership experience of minimum 3 years in a similar capacity \u2013 4 or more employees\n\n\n * Proven ability to manage shifting priorities in a dynamic environment \n\n\n\nPreferred qualifications:\n\n * Boston Scientific experience is preferred\n * Preferred experience with Operational Excellence \u2013 process optimization, problem solving, Six Sigma, Lean methodologies\n * Demonstrated experience or collaborating and communicating with regulatory bodies\n * Proven experience working with competent authorities and notified bodies \u2013 FDA, BfArM, HPRA, etc.\n * Proven experience with Electrophysiology products\n * Preferred experience with Post Market activities \u2013 complaints, vigilance, CAPA\n * Proven experience supporting internal or external audits\n * Proven vendor management experience \u2013 oversight and execution of post market process\n\n\n\nRequisition ID: 626450\n\nMinimum Salary: $ 71500\n\nMaximum Salary: $ 135800\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will 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.\n\nCompensation 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).\n\nCompensation 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).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nBoston 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. Learn more at www.bostonscientific.com and follow us on LinkedIn.\n\nBoston 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.\n\nPlease 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\u2019s policies or protocols change with regard to COVID-19 vaccination.\n\nAmong 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. \n