COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is hiring a Senior Project Manager, Regulatory Affairs / Mergers & Acquisitions (Onsite, Hybrid, or Remote).

It is preferable that onsite or hybrid candidates live within a reasonable commuting distance to the Allendale, NJ, Shirley MA, or Leesburg, VA facility. However, the role may also be performed remotely with limited travel required to Shirley, MA, Leesburg, VA, or Allendale, NJ.

No matter where you are located, you must be available to be onsite for audits or prescribed occasions (around 10% travel).

If remote, this job may be performed remotely anywhere in the United States, except that this job may not be performed in Colorado.

Who we want

• Dedicated achievers. People who are relentless about quality, that thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Goal-oriented developers. Keeping the customer and system requirements squarely in focus, we are looking for people who deliver safe and robust solutions.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

• Lead and drive projects of varying complexity as a quality and regulatory leader, including those that focus on the implementation of new global regulations (EU MDR, UKCA, etc.) throughout the QMS, quality system improvements, as well as QMS related business projects such as mergers, acquisitions, or manufacturing transfers.

• Ensure QMS compliance with the appropriate internal and external regulatory requirements, perform the necessary gap assessments and maintain awareness of the overall regulatory landscape.

• Responsible for assembling project teams, assigning individual responsibilities, identifying resource needs, and developing schedules to ensure timely completion of projects.

• Identify detailed project requirements, constraints, and assumptions with stakeholders to establish project deliverables.

• Drive the identification, assessment, monitoring, and resolution of project risks.

• Responsible for improving team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating to facilitate cooperation, ensure project efficiency and boost morale.

• Manage QMS activities to support the achievement of project milestones.

• Identify and deliver strategic and futuristic improvements and inputs into the quality system, ensuring it reflects actual activities, business needs, and compliance requirements.

• Guide the development, maintenance, and improvement of policies and procedures to increase the efficiency and effectiveness of the QMS.

• Drive the development of best-in-class practices and benchmark against industry leaders and regulatory requirements.

• Represent expertise during internal and external quality system audits, while often playing key audit support roles.

• May coordinate the activities of one or more exempt and/or non-exempt employees

What you need

• BA, BS, or equivalent (emphasis in engineering, sciences, quality, regulatory or related discipline preferred).

• Minimum of 7+ years of experience in the medical device industry or an equivalent regulatory environment, with a focus on quality systems and/or regulatory affairs.

• Thorough knowledge and understanding of US and international medical device regulations, including those of the EU and MDSAP regions.

• Project management skill sets or experiences are highly advantageous.

• Experience managing QMS related compliance or improvement projects (interpretation and compliance to new or existing regulations and standards).

• Experiences with managing QMS impacts related to organizational changes and/or business initiatives such as mergers, acquisitions, and business divestitures/site closures are highly preferred.

• Experience performing and managing external audits by Notified Bodies, Regulators, or other Agencies / Accreditors.

• Experiences with orthopedic, human, and animal tissues products and/or electrical medical devices are advantageous.

• Experiences with foundational QMS processes required – for example, NC/CAPA, document controls, change control, etc.

• Demonstrated ability to lead a team of individual contributors with authority, while not having direct management responsibility.

• Demonstrated excellent communication skills and the ability to work with employees at all levels of the organization.

• Strong communication, organization, and influencing skills.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com