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Stryker Senior Staff Regulatory Affairs Specialist (Remote) in Shirley, Massachusetts

Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

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

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.

We are currently seeking a Senior Staff Regulatory Affairs Specialist for New Product Development within our Spine Enabling Technologies unit; may be based remotely anywhere in the United States.

Who we want

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

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

What you will do

As a Spine Enabling Technologies Senior Staff Regulatory Affairs Specialist, you can expect to set complex regulatory strategy to support global expansion of Spine’s Enabling Technology products, including our Airo Mobile CT System. You will support product development activities in a cross-functional team structure to advise them in successful and least burdensome regulatory approaches and appropriate use of design controls for intricate devices subject to medical electrical requirements, 21 CFR Subchapter J, and software and cybersecurity requirements. Opportunity exists to seek strategy collaboration and execution with other Stryker divisions for complex device systems. You will ensure regulatory compliance and support on-time launches by conducting detailed regulatory planning and completing the appropriate submissions for product clearances/approvals by FDA, Notified Bodies, and other global regulatory bodies.

  • Evaluates the regulatory environment and provides internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.

  • Determines requirements (local, regional, global) and options for regulatory submission, approval pathways, and compliance activities.

  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.

  • Provides regulatory information and guidance for proposed product claims/labeling.

  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency.

  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

What you need

  • A Bachelor’s degree required; in Engineering, Biological Sciences or equivalent focus preferred.

  • A minimum of 7 years of working in a FDA regulated industry required.

  • A minimum of 4 years of Regulatory Affairs experience required.

  • Previous experience authoring 510(k)s and other regulatory submissions required.

  • Experience interacting with regulatory agencies required.

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

  • Strong leadership skills.

  • Demonstrated success in management of global regulatory strategy and submission activities required.

  • Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).

  • Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.

  • Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.

  • Strong interpersonal, written and oral communication skills.

  • Good time and project management skills with the ability to multi-task.

This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.

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

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