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Senior Regulatory Affairs Specialist (Remote) (R450316)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Kalamazoo, Michigan, 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 Specialist to join our Medical Division to be based in Portage, MI or remotely within any state located within the Central Standard Time Zone or the Eastern Standard Time Zone.

Who we want

  • 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 the Senior Regulatory Affairs Specialist, you will be responsible for the coordination and preparation of change assessments and document packages for regulatory submissions in the United States. You will be a collaborative team player who is interested in bringing and sustaining products on the market via pre-market submission activities with global Health Authorities. You will liaise with internal and external customers and establish strong relationships with the FDA. You are responsible global product field action process. You will translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes. You will be motivated to act while taking on projects of greater complexity under limited supervision.

  • 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.

  • 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.

  • Negotiate with regulatory authorities throughout the product lifecycle.

  • 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 propose plans/strategizes (if appropriate) for changes that do not require submissions.

  • 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 3 years of experience in an FDA or highly regulated industry required.

  • A minimum of 1 year in a Regulatory Affairs role preferred.

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

  • General understanding of product development process and design control preferred.

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

  • Previous experience with US Class II/III medical devices 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