The Director, Device Quality Systems (EU&ROW) is responsible for partnering with the corporate Medical Devices and Combination Products (MDCP) Quality team to support implementation of MDCP Quality strategy implementation.
The incumbent will be accountable for ensuring that all applicable Medical Device and Combination Product Regulations are incorporated within relevant corporate quality policies (Pfizer Quality Standards) and primarily responsible for EU & ROW requirement monitoring and implementation support.
- Provides technical leadership and serves as Medical Device EU & ROW QS regulations Subject Matter Expert (SME) within the corporate Quality Systems & Compliance organization.
- Actively communicate and collaborate with internal and external partners and across functions and divisions such as Engineering, Regulatory, Site Quality, Operations, Clinical/Safety, R&D etc.
- Owns the creation and content maintenance of new corporate quality policies (Pfizer Quality Standards) as assigned and supports global site implementation.
- Leads rollout and implementation of targeted device QMS compliance activities across key pilot sites.
- Leads gap assessments against new regulations and relevant inspectional observations to ensure necessary corporate policy updates are identified and implemented.
- Supports medical device and combination product technical inspectional readiness activities and regulatory inspection responses as needed.
- May also direct the activities and work product of device quality consultants.
“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.”
- Bachelor’s Degree in Engineering and 15+ years total progressive work experience in R&D/Engineering and Quality at a global manufacturer of medical devices.
- Expert working knowledge of the EU Medical Device Directive (MDD) 93/42/EEC and advanced level understanding and working experience with gap assessments to the EU Medical Device Regulation (MDR) 2017/245 and relevant industry standards.
- Proven success working and negotiating with people from various disciplines, organizations, and cultures.
- Strong attention to detail. Ability to work in a highly matrixed and geographically diverse business environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Significant experience performing gap assessments between regulatory requirements, corporate quality policies/standards and records.
- Expert knowledge of 21 CFR Part 820, MDD, MDR and ISO 13485.
- Track record of leading successful medical device and combination products Quality Systems improvement projects
- Demonstrated experience authoring responses to device regulatory agencies.
- Excellent analytical, organizational, communication, and interpersonal skills are required.
- Corporate level device leadership role experience is desired in addition to direct experience implementing solutions across multiple global sites.
- Ability to work independently in a highly matrixed organization.
- Experience with postmarket surveillance obligations
- Successful track record of interacting with EU Competent Authorities, notified bodies, registrars and other Rest of World boards of health as required specific to medical device related activities.
- Master’s Degree in Engineering or closely related technical field.
- Some knowledge of pharmaceutical regulations is desirable
- Overall operational and financial acumen, Business and Project Management skills and experience a plus.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
15-20% travel (may vary and be higher initially as required)
Some international travel is required.
Other Job Details:
Last Date to Apply for Job: July 17, 2020
* Eligible for Employee Referral Bonus: Yes
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EEO & Employment Eligibility
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