Staff Regulatory Affairs Specialist, Software (Remote)

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: 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

Stryker is one of the world’s leading medical technology companies and together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics 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 aStaff Regulatory Affairs Specialist to join our Digital Robotics & Engineering (DRE) team, this position is Remote or Hybrid in the USA. Preference to Eastern and Central states to align with global partners.

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

Possesses and applies knowledge, skills/abilities, and understanding of the regulatory and legal frameworks, regulatory requirements, and processes and procedures focused in the areas of DREs Digital portfolio. This includes but is not limited to Clinical Decision Support Software, Extended Reality (XR), and Artificial Intelligence / Machine Learning (AI/ML), and cloud and other connected devices and platforms. This position will work in close collaboration with DREs Commercial Division partners to provide knowledge and guidance to new product development teams.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
• Evaluates the regulatory environment and contributes to providing 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.
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  Evaluates proposed products for regulatory classification and jurisdiction.
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
• Negotiates with regulatory authorities throughout the product lifecycle.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Assists other departments in the development of SOPs to ensure regulatory compliance.
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams.
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
• 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 knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process.
• 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 minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
• A minimum of 5 years of experience in an FDA or highly regulated industry required.
• A minimum of 2-3 years in a Regulatory Affairs role required.
• Experience with software as a medical device, Agile development, and/or artificial intelligence preferred.
• RAC(s) desired

• $83,000- $136,000salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.
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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.