Director, Device Standards and Compliance

The Device Standards and Compliance Director is responsible for partnering with the Medical Devices and Combination Products (MDCP) Quality Systems Sr Director in direct support of the MDCP Quality strategy implementation within the corporate MDCP Quality Systems organization.

The incumbent will be accountable for monitoring external device standards applicable to medical devices, software as a medical device, in-vitro diagnostics and combination products for corporate QMS updates as required to ensure compliance with all applicable regulations.

ROLE RESPONSIBILITIES

• Actively communicate and collaborates with internal and external partners and across functions and divisions such as Engineering, Regulatory, Site Quality, Operations, Clinical/Safety etc.

• Owns the development and rollout of device standards lists by product types/families and ensures these are kept up to date.

• Participates actively on relevant external industry committees and ensures that and ensuring existing policies are in compliance with all applicable medical device and combination product regulations including SaMD & In Vitro Diagnostics.

• Leads gap assessments against new regulations and relevant inspectional observations as required.

• Authors articles for the Pfizer regulatory intelligence newsletter

• Completes impact assessment of new regulations and document applicability

• Monitors external device enforcement trends and provides detailed recommendations and action plans to address QMS improvements.

• Supports medical device and combination product inspectional readiness activities and regulatory inspection responses as needed.

• Maintains current knowledge of external legislation, standards, guidelines, industry practices, and FDA submission requirements that impact medical devices and combination products.

• Maintains active memberships and participation within relevant external medical device and combination product industry groups and committees.

BASIC QUALIFICATIONS

• Bachelor’s Degree in Engineering or closely related technical field.

• 10+ years of progressive work experience at a global manufacturer of medical devices or at a regulatory agency.

• Experience creating policies in a corporate quality function and review, assessment and management of device standards

• Leadership experience on external committees such as AAMI, ASQ, RAPS etc.

• Expert knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304 etc.

• Track record of leading successful medical device and combination products compliance improvement.

• Strong analytical, organizational, communication, and interpersonal skills are required.

• Strong negotiation and collaboration skills with an ability to work independently in a highly matrixed organization.

PREFERRED QUALIFICATIONS

• Master’s Degree in Engineering or closely related technical field.

• Some knowledge of pharmaceutical regulations is desirable

• Current/Past ASQ Credentials are required such as CQE, CQA, CRE, CBA.

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.

OTHER POSITION DETAILS

• Last Date to Apply: April 27, 2022

• Approximately 10 to 15 percent travel (may be higher at particular periods of the year)

• Position can be remote; in US preferred

• Relocation support available

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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