Staff 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 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

We are currently seeking a Staff Regulatory Affairs Specialist to join our Spine Division to be based in Allendale, New Jersey or remotely anywhere within the United States.

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.

• 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.

What you will do

As a Staff Regulatory Affairs Specialist, you can expect to set Regulatory Affairs strategy for changes made to the device post-launch to determine regulatory impact of changes to the current clearance/approvals. You also ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances or approvals by FDA, Notified Bodies and other regulatory bodies.

In this role, you are the Stryker Spine division subject matter expert for the regulatory and business requirements. You are actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business and organizational activities, management and strategy.

WHAT YOU WILL DO:

• Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

• Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

• Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).

• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.

• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

• Negotiate with regulatory authorities throughout the product lifecycle.

• Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

• Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

• Assist other departments in the development of SOPs to ensure regulatory compliance.

• Provide regulatory input and technical guidance on global regulatory requirements to product development teams.

• Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

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

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

WHAT I WOULD RECOMMEND USING:

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

• A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices.

• A minimum of 3 years of Medical Device 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 and international medical device regulations.

• Previous experience with Class II/III medical devices preferred

• Previous experience drafting regulatory submissions required

• 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.

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