Senior Regulatory Affairs Specialist, (Hybrid) - Military Veterans

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

We are currently seeking an Senior Regulatory Affairs Associate to join our Acute Care business unit, Hybrid, to be based in Portage, Michigan.

Who we want

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


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


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


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  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.


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  Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As the Regulatory Affairs Specialist, you will support Stryker’s Acute Care portfolio for our global market. You will be responsible for maintaining global market access by analyzing the impact of device modifications and emerging regulatory intelligence. You will help identify global regulatory requirements to support new product development. You will enable global product sales in new markets by liaising with global Stryker teams to execute registrations in accordance with health authority requirements.

• Evaluate device modifications and takes appropriate action to ensure global product compliance.


• Support new product development in submitting registrations and subsequently support registration renewals in global markets.


• Analyze and advise on the impact of emerging regulatory intelligence.


• Provide regulatory input and technical guidance on global regulatory requirements to product development teams.


• Determine requirements and options for global regulatory submissions, approval pathways, and compliance activities.


• Prepare and submits regulatory submissions according to applicable regulatory requirements and guidelines in global markets.


• Participate in preparation and execution of audit required to enable of maintain market access.


• Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.


• A minimum of 2 years of experience in an FDA or highly regulated industry required.


• A minimum of 1 – 2 years in a Regulatory Affairs role required.


• Previous experience with Class II/III medical devices preferred.


• Previous experience drafting 510(k)s preferred.


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


• Experience authoring regulatory submissions for product approval preferred.


• Experience interacting with regulatory agencies preferred.


• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.


• Ability to analyze and resolve non-routine regulatory issues using independent judgment.


• Excellent analytical and writing skills.


• Excellent interpersonal, written and oral communication skills.


• Effective organizational skills.


• Advanced PC skills with proficiency in Microsoft office Suite, including Excel.