Senior 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

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Regulatory Affairs Specialist to join our Spine Division to be based in Allendale, New Jersey and/or Leesburg, VA or remotely in New York, Pennsylvania, Maryland, or Connecticut.

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.

• Self-directed initiators. 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.

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

What you will do

As the Senior Regulatory Affairs Specialist, you will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will support OUS registration any regulatory support required to ensure continued market assess across all three Stryker Spine locations You will support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

As the Senior Regulatory Affairs Specialist, you will 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 Bachelor’s Degree (B.S or B.A) required; in Engineering, Science preferred.

• A minimum of 3 years of experience in an FDA regulated industry required; preferably within medical devices.

• A minimum of 2 year of Regulatory Affairs experience required.

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

• General understanding of product development process and design control.

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

• Thorough understanding of FDA, Europe and international medical device regulations.

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

• Previous experience drafting 510(k)s preferred.

• Experience drafting 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.

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/