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Senior Regulatory Affairs Specialist, Enabling Technologies (Remote) (R465294)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Shirley, Massachusetts, United States

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one 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

Our benefits include 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.

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.

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, Enabling Technologies to join our Spine Division to be based in Allendale, New Jersey, Leesburg, VA or Shirley, MA or remotely in New York, Pennsylvania, Maryland, New Hampshire, Rhode Island, Vermont or Connecticut with the ability to be a commutable distance to one of the core locations as needed.

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, Enabling Technologies 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:

  • 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

  • Evaluate proposed products for regulatory classification and jurisdiction

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

  • Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

  • 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

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

  • Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships

  • Identify, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

  • 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; 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.


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/

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