Senior Staff Regulatory Specialist, Pharmaceuticals

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, 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 a Senior Staff Regulatory Affairs Specialist to join our Medical Division. This is a hybrid role based in Cary, IL.

Who we want

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.

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

• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

What you will do

As a Senior Staff Regulatory Specialist, you will be exposed to a diverse product portfolio that includes pharmaceutical, cosmetic and medical device products. This role is part of a growing and evolving Regulatory Affairs team that is focused on aligning and integrating to the Stryker global business. The ideal candidate will have strong project management skills including the ability to communicate effectively to a diverse set of stakeholders. In this role, you will:

• Prepare and author FDA INDs and NDAs, as well as annual reports.

• Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.

• Assess and author amendments and supplements to product marketing applications.

• Provide regulatory guidance to other departments for planned changes.

• Provide a critical detailed review of technical documentation prior to FDA submission.

• Compile information and data pertaining to regulatory and project requirements including assessing needs; identifying the project's critical factors; presenting decision-makers with options; and applying strategies.

• Communicate with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions, and follow-up on submissions in review.

• Serve as partner to marketing, engineering, clinical and quality on project and product development teams.

• Improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.

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 7 years of experience in an FDA or highly regulated industry required.

• A minimum of 5 years in a Regulatory Affairs role required.

• Must have pharmaceutical experience. Experience with medical device products would be a plus.

• Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions.

• Travel Required: Up to 25%

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.