C2C-Remote -Senior Technical Project Manager-FDA, GXP and technical (18962-1)

Hi,
Hope you're doing well.

My name is Chandan, and I am a Recruitment Manager from Empower
Professionals Inc. We are sourcing for a Senior Technical Project
Manager-FDA, GXP and technical (18962-1) role located at Remote and it's
a long-term contract with possible extensions.





If you're skills match the job description, please share your updated
resume along with your location and expected rate so that I can get in
touch with you for further process.




Role: Senior Technical Project Manager (18962-1)

location: Remote

Duration: 12+ Month



Level


Skill


Core Concepts

Expert


Product Lifecycle Management (PLM) Systems


Windchill, Teamcenter, Change Management, Product Data Management,
Configuration Control

Expert


Medtech Regulatory Compliance Knowledge


FDA 510K, PMA, UDI, CE mark, EU MDR, GxP, FURLS, BUDI

Expert


Stakeholder Management and Influence


Cross-functional influence, Stakeholder mapping, SME engagement,
Interpersonal diplomacy

Proficient


Cross-OUs Regulatory Process Navigation


Medtronic OUs, OU-specific compliance variance, Inter-OU collaboration

Proficient


Regulatory Strategy and Workstream Ownership


Strategic planning, Business process modeling, Scope-risk
interdependencies, ROI tracking

Proficient


Change Management


OCM, Stakeholder readiness, Training planning, Resistance management

Competent


Agile Program Delivery and Testing


Scrum, Sprint Planning, User Acceptance Testing, Test script development

Competent


KPI and Performance Monitoring


Performance metrics, ROI, Cost-benefit analysis, Workstream evaluation





Please find the below Notes from the Client



Ensure candidates are technically strong + interpersonal rockstars

Technical & Domain Experience

Strong PLM (Product Lifecycle Management) expertise

Deep knowledge of Medtronic-specific processes and regulatory landscape
(especially medtech and FDA/GxP compliance)

Familiarity with engineering and regulatory operations across different
Medtronic Operating Units (OUs)

✅ Soft Skills (High Priority)

Bridge-building & interpersonal communication: Must work across OUs with
teams that have different regulatory processes and resist change

Ability to facilitate agreement across diverse stakeholders with
different viewpoints

Exceptional listening and diplomacy skills to manage experienced SME
teams

✅ Strategic Role Characteristics

Ability to gain trust and drive consensus in a complex, change-resistant
environment

Comfortable with both high-level strategic discussions and deep
technical/regulatory details

Value in someone who is not just technically capable but a true
influencer and integrator





Job Description:

Bachelor's degree and a minimum of 9+ years of relevant experience
including broad multi-functional business experience along with 5+ years
of project and/or people management experience, or - Master's degree and
a minimum of 5 years of relevant experience including broad
multi-functional business experience along with 3-5 years of project
and/or people management experience.
Solid program manager experience with a drive for continuous
improvement and a passion to be a change agent.
Strong leadership skills with proven record of managing successful
projects/teams.
Experience implementing initiatives through effective influence
management skills at multiple levels in the organization.
Must be comfortable with ambiguity, adept at change management, and
capable of working in cross functional teams.
Excellent facilitation and issue resolution skills.
Experience leading efforts in an FDA/ISO regulated environment. -
Familiarity with regulatory submissions (e.g. Q, 510K, PMA, UDI, FURLS,
CE mark, BUDI, etc.) to governing bodies such as FDA, EU, Korea, China,
etc., their local notified bodies and regulatory agencies.
Familiarity with the evolving regulatory landscape and how that
needs to influence the data model attributes related to regulatory
submission and device registration as well as the progression from
manual submission towards automated submission between medical device
companies and regulatory bodies.
Familiar with the connection between regulatory submissions needed
with respect to product changes requiring updated GTS licensing.
Experience with medical device product development to ensure that
regulatory issues are addressed as an integral part of the enterprise
change control process.
Knowledge and understanding of EU MDR requirements.




--
Thanks

Chandan

Manager | Empower Professionals

........................................................................................................................................................

chandan@empowerprofessionals.com |
100 Franklin Square Drive – Suite 104 | Somerset, NJ 08873

www.empowerprofessionals.com

Certified NJ and NY Minority Business Enterprise (NMSDC)
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