Manager, Medical Device

Use Your Power for Purpose

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

This position is part of Pfizer's Medical Device and Combination Products (MDCP) Quality Operations team. As Manager of Medical Device Quality Assurance Development, you will be responsible for ensuring that product development teams comply with design control and regulatory standards (21 CFR 820, ISO 13485, ISO throughout the entire product lifecycle. The role supports the delivery of the Medical Device and Combination Products development portfolio in collaboration with the Pfizer Pharmaceutical Sciences Organization. You will work closely with cross-functional teams to establish innovative methodologies, facilitate agreements, and rigorously review deliverables to guarantee product safety, compliance, and efficacy. Your specialized knowledge will contribute to achieving team goals within Pfizer's quality system, necessitating exceptional communication, analytical, and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues, communicate across all organizational levels, prioritize quality, assist in completing critical deliverables, clarify complex matters, and foster effective teamwork.

How You Will Achieve It

• Oversees and ensures compliance with SOP's, quality standards (e.g. 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO and regulatory requirements, including conducting audits, identifying areas for improvement, and implementing corrective actions.

• Routinely provides guidance and interpretation of SOP's and standards within PharmSci and with external partners.

• Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls, risk management, quality management systems, change controls, vendor management, and complaints.

• Monitor changes to global regulations and ensure policies and procedures reflect applicable changes, implements quality system best practices, and communicates company-wide policies on quality system effectively.

• Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement initiatives with the MDCP space.

• Proactively seeks global alignment / interpretation in application of policy / procedure.

• Has technical and quality knowledge on later phase product life cycle strategies (e.g. design verification, design validation, process validation, ICH stability, etc.). Leads and advises as needed.

• Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues

• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

• Strong leadership, negotiation, interpersonal, communication, and facilitation skills

• Strong analytical and computer skills are required.

Bonus Points If You Have (Preferred Requirements)

• The combination of strong pharmaceutical and / or medical device development experience preferred

• Thorough understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR "4" current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems

• Extensive experience in risk managementand design control of medical devices, combination products from concept through launch, or pharmaceutical manufacturing operations in a GMP environment

• Proven ability to succeed in a fast-paced, challenging, and complex environment

Non-Standard Work Schedule, Travel, or Environment Requirements

• The role may include frequent business travel across Pharmaceutical Sciences, vendors, and suppliers.

Other Job Details

• Work Location Assignment:Hybrid - On premise 2-3 days per week at a Europe, US, Latam, Central America Pfizer location

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $96,300.00 to $160, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.  This position requires permanent work authorization in the United States.

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Quality Assurance and Control

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