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Senior Manager, Medical Device Technology, Complaint Handling

Company: Pfizer
Location: San Jose
Posted on: May 28, 2023

Job Description:

Senior Manager, Medical Device Technology, Complaint Handling page is loaded Senior Manager, Medical Device Technology, Complaint Handling Apply locations United States - California - San Jose United States - California - Berkeley time type Full time posted on Posted Today job requisition id 4884855 Why Patients Need You -Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. -What You Will Achieve -In this role, you will lead Complaint Investigation process and execution for product design and process related complaints for our Post-Market Medical Device and Invitro Diagnostic (IVD) products within our Design Engineering team. As a member of the team, you will ensure that all applicable Medical Device Regulations for Complaint Handling are incorporated within local SOPs and work instructions and followed. -You are responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. -As a Senior Manager, you will be setting the objectives for your team and organization. Your managerial and technical skills will help in guiding the colleagues and / or contractors in your team. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success. -Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare. -This is an onsite position that will be located in San Jose or Emeryville, CA. How You Will Achieve It -

  • Maintain a compliant process for Complaint Files aligned with 21 CFR Part 820.198 -
  • Maintain a complaint process for Post marketing Safety Reporting (PMSR) aligned with 21 CFR Part 4, Subpart B -
  • Specialize in leading complex cross-functional investigations teams, signaling/trending within and across complaint data -
  • Manage the work of others to maintain and improve complaint investigation -
  • Ensure appropriate and timely flow of complaint investigation review and approval -
  • Enable a culture of continuous improvement by identifying opportunities for improvements and leading/participating in project activities -
  • Support proactive post market surveillance activities on as needed basis to support department objectives and business needs -
  • Lead complaint monitoring and trending activities. This includes but is not limited to: -
  • Generating data for analysis and management review -
  • Internal and external audits and field actions as necessary -
  • CAPA process activities for product related issues. -
  • Consult with other groups to compare observed rates to established expectations and to determine when observed trend should be escalated for additional investigation -
  • Provide post market surveillance data for new product development and product improvements -
  • Establish and maintain relationships with manufacturing sites, Quality Operations, and other key stakeholders to drive successful product investigations -
  • Work with software partners to enhance existing complaint handling systems. Participate in software verification and validation when required -
  • Lead policies, procedures, and work instructions updates as needed -
  • Keep management informed of significant complaint trends -
  • Lead a team to develop and enhance connectivity between Quality and Engineering investigation resources -
  • Experience in Regulatory Agency/Health Authority interactions -
  • Experience in working with Combination Products and Medical Devices -Qualifications -Must-Have -
    • Bachelor's Degree and 7+ years of experience in complaint handling. -
    • Experience working with and knowledge of 21 CFR Part 4 Subpart B, 21 CFR 211.198, 21 CFR 820.198, and 21 CFR Part 803. -
    • Ability to work independently in a highly matrixed organization. -
    • People Management experience. -
    • Strong leadership skills in managing high performing teams. -
    • Strong verbal, written and interpersonal communication skills. -Nice-to-Have -
      • Master's degree and relevant pharmaceutical experience. -
      • Excellent understanding of local regulations around good manufacturing practices for finished pharmaceuticals. -
      • Experience in relevant guidelines, operations and/or quality. -
      • Demonstrated experience with leading teams responsible for post market complaint investigations for medical devices and combination products. - -
        Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. -
        -PHYSICAL/MENTAL REQUIREMENTS -
        • Office-based role supporting virtual teams. Flexibility required when working with global colleagues in various time zones -NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS - -10-15% travel (may vary and be higher initially as requiredOther Job Details:
          • Last Date to Apply: May 24, 2023
          • Relocation assistance eligible: Yes
          • Employee referral eligible: YesThe annual base salary for this position ranges from $127,400.00 to $212,200.00. In addition, this position offers an annual bonus with a target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Quality Assurance and Control#LI-Remote #LI-PFE About Us Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, San Jose , Senior Manager, Medical Device Technology, Complaint Handling, Executive , San Jose, California

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