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Senior Staff Regulatory Affairs Specialist (Remote)

Equipment/Technology Specialist

Equipment and Facilities Specialist

No

Allendale, New Jersey, United States

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 Senior Regulatory Affairs Specialist to join our Spine Division to be based remotely in Virginia, New Jersey, 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.

  • 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.

  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

What you will do

As the Senior Staff Regulatory Affairs Specialist, you will support Stryker’s Core Spine portfolio new product development for both US and OUS global regulatory release by creating and updating regulatory strategies. 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 or approval. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, review labeling and marketing materials, evaluate proposed device changes, and interact with FDA, Notified Bodies, and other regulatory agencies. Stryker’s Spine business unit offers one of the most comprehensive and diverse product portfolios, including leading 3D-printed technologies, enabling surgeons to provide their patients with treatment options. This role will support the cutting edge of spinal solutions, including implants, instruments, and biologic solutions for the cervical, thoracic, and lumbar spine.

  • Evaluate the regulatory environment and provides 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.

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

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

  • Compare regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.

  • Negotiate with regulatory authorities throughout the product lifecycle.

  • Identifies 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.

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

  • Provide regulatory information and guidance for proposed product claims/labeling.

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

  • Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

  • Monitor the progress of the regulatory authority review process through appropriate communications with the agency.

  • Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

  • Work 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; preferably in Engineering, Science, or equivalent focus.

  • A minimum of 7 years of experience in a regulated industry required; preferably within medical devices.

  • A minimum of 5 years 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 and international medical device regulations.

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

  • Previous experience with 510(k)s required.

  • Experience drafting regulatory submissions for product approval highly preferred.

  • Experience interacting with regulatory agencies preferred.

  • Experience with EUMDR regulations and guidelines highly 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/