Sr. Regulatory Program Manager - ECR

Job title – Sr. ECR Regulatory Program Manager 
 
Job Location – Bothell WA 
 
Length – Contract (6 Months+) 
 
Job Description -
Experience: Minimum 20 years professional experience in the applicable role. 
 
Education: Bachelor's /Master's degree or equivalent. 
 
Responsibilities - 
Client is driving an organization wide transformation program – set out to unlock ECR's full potential, fixing our foundation, and turning us into a more agile, entrepreneurial and customer focused business unit.  Ultimately, our transformation is all about achieving excellence in execution and meeting our commitments, where all parts of the organization effectively work together to drive success in all activities across our BU. We are redesigning our organization and how we work, focusing on delivering value for our customers, improving our processes, techniques and practices and creating a winning team by living our behaviors and building our capabilities for the future. 
 
The Sr. Regulatory Program manager will fulfill the role as the strategic leader for process optimization and product development projects with a focus on supporting the Regulatory Affairs team. The successful candidate will have strong program and project management experience, servant leadership skills, demonstrated by the ability to influence and lead within a rapidly evolving, cross-functional, and highly regulated environment. The Sr. Program manager will be responsible for the performance of multiple teams and for adherence to company procedures, applicable regulations and standards to achieve the agreed upon project objectives. The candidate will lead planning activities for multiple projects, track progress, aggressively pursue opportunities and proactively mitigate risks. 
 
Key Responsibilities: 
 
• Participating in the framing, scoping, and support of Projects within the regulatory affairs space, that may consist of a variety ofcompliance-related projected, , critical ECR BU projects/programs, and new product development programs/projects.. 
• Drive strategic complex projects and/or programs ensuring they are executed according to Q&R strategy and goals within the ECRbusiness unit. 
• Project management of activities at supplier and/or within business unit to improve product quality, reliability and delivery. 
• Monitor and execute plans according to project key metrics/targets, budgets and deliverables as well as develop and coach personnel to ensure efficient operation of the project functions. 
• Responsible for gaining agreements on and achieving project objectives, balancing schedule, regualtory, quality and requirements. Ensuring effective introduction of products, technologies, systems, solution or services. 
• Program management experience – experience leading multiple projects and teams which require significant cross-functional involvement and product change integration within current production 
• Developing and managing program plans including: schedules, resourcing, budgeting, and communication with leadership on multiple projects 
• Proactively evaluating multiple project for opportunities to improve performance at a program level 
• Being ultimately accountable for team’s compliance with approved project plans 
• Continuous monitoring of project and compliance risk, and mitigation as appropriate 
• Facilitate rollout of new regulatory initiatives, including moderating regulatory training/workshops 
• Escalation of cross-functional support issues to the manager or leadership as appropriate 
• Providing daily direction and guidance to team members in the execution of the project 
• Assist and advise Project Sponsors, Innovation Managers, and teams to the best use of project management disciplines, processes and techniques to enable and accelerate individuals and teams. 
• Establish strong operating mechanisms, which include clear and timely communication with the Q&R leadership team and stakeholders. 
• Report out on project status, manage critical path items, ensuring risks and roadblocks are identified, removed and/or mitigated to ensure deliverables are met. 
• Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization. 
• Providing guidance and coaching/mentoring to team members and other project leaders as appropriate. 
• Understand the needs of internal and external PMO stakeholders and contribute to their success through cooperative and cross-functional processes.  (Live our mission to enable and accelerate the ECR BU). 
• Act as a reference point for PMO queries and information and an advocate for best practices in project management, project framing, project resourcing, and project delivery. 
• Design, iterate and improve the project management framework and disciplines necessary to support a best of breed PMO that enables and accelerates our business unit in the delivery of value for our customers. 
• Track and report on regulatory project portfolio performance, providing a real-time, comprehensive, and prioritized view of all projects. 
 
Desired Attributes of the Role: 
 
• Leadership skills (a Servant Leader) 
• Full lifecycle project and program management 
• Excellent written, verbal and presentation skills 
• Relational Skills 
• People skills 
• Team building skills 
• Interpersonal skills 
• Operating skills 
• Practice in getting work done in partnership with others 
• Results Oriented 
• Functional 
• Business Acumen 
• Collaboration 
• High EQ 
• Empathy 
• General knowledge of medical device regulatory affairs preferred 
 
Best, 
Kushal Shah 
APN Software Service INC 
kushal@apninc.com 

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