Principal Regulatory Affairs Specialist- (Remote)

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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Why regulatory affairs/quality assurance 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. 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are currently seeking a Principal Regulatory Affairs Specialist to join our Stryker Neurovascular to be based in Freemont, California or remotely anywhere within the United States.

WHO WE WANT:

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

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

• 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 will support Stryker’s Neurovascular M&A, Integration and New Products Development activities. You will provide regulatory guidance and support during scoping, planning and execution activities required to integrate new acquired business into Stryker Neurovascular. You will also prepare complex submission to gain approvals for clinical studies and commercial distribution in the United States and OUS. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, provide guidance to integrate regulatory requirements into global product commercialization strategy.

• Identifies regulatory pathways for initial product designs and provides input to internal stakeholders

• Provides strategic input and technical guidance on global regulatory requirements to product development

• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles

• Critically assesses the impact of changing regulations on pre-approval and post approval strategies and approaches based on changing regulations

• Negotiates with regulatory authorities on complex issues throughout the product lifecycle

• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures

• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions

• Review and assesses proposals to regulatory authorities on regulatory paths and clinical plans

• Provides regulatory guidance on strategy for proposed product claims/labeling

• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims

• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions

• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process

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

• 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

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• 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

• 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

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

WHAT YOU NEED:

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

• A minimum of 9 years of experience in an FDA regulated industry required; preferably with medical devices.

• A minimum of 7 years of Medical Device Regulatory Affairs experience required.

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

• Experience in M&A and Integration activities preferred.

• Thorough understanding of FDA and international medical device regulations.

• General understanding of product development process and design control.

• General understanding of regulations applicable to the conduct of clinical trials.

• Previous experience with Class II/III medical devices required

• Previous experience drafting regulatory submissions to FDA required

• Experience interacting with regulatory agencies required

• 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.

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

Our benefits

Our total rewards offering varies by country but often includes 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.

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/