Principal Regulatory Affairs Specialist, (Hybrid)

Location

Portage, MI | United States

Job description

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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance 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 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 

We are currently seeking a Principal Regulatory Affairs Specialist to join our Instruments Division based Hybrid in Portage, Michigan .

Who we want

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• 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 the Principal Regulatory Affairs Specialist, you are a key expert, the job requires in-depth knowledge and understanding within one discipline. They are regarded within the organization as a technical 'expert' in their field. The job requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze, and validate potentially complex and dynamic material.

• Works with minimal supervision and instruction of more experienced staff
• Takes a technical leadership role on one or more projects of significance.
• Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations.
• Demonstrates developing leadership skills.
• Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
• Demonstrates strong technical and developing management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities, management and strategy.
• Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and management; monitoring and communicating change in the regulatory environment as well as global communication; staff and vendor development and management; and influencing the regulatory environment.
• Plans, conducts, and supervises assignments, reviewing progress and evaluating results.
• Recommends changes in procedures.
• Operates with substantial latitude for independent action or decision, and reviews progress with management.

What you need

• A Bachelor’s degree required; in Engineering, Biological Sciences or equivalent focus preferred.
• A minimum of 9 years of working in a FDA regulated industry required.
• A minimum of 7 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.

About Stryker

Our benefits:

• 12 paid holidays annually

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more:  US Stryker employee benefits

About Stryker
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  stryker.com.

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 on our  referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

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