Senior Staff Regulatory Affairs Specialist

18 Jul, 2022

Jobs

Senior Staff Regulatory Affairs Specialist

Stryker
Mahwah, NJ

Why RA/QA 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 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

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.

 

This is a hybrid position, which requires travel to the Mahwah NJ or Weston FL site on an as-needed basis.

 

Who we want

 

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

 

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.

 

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.

 

What you will Do

 

As the Senior Staff Regulatory Affairs Specialist, you will bring and sustain products on the market while working in a fast-paced cross-functional and collaborative team environment.

 

  • Apply advanced knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.
  • Identify requirements and potential obstacles for maintaining products on the global markets
  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Evaluate medical device regulations and develop strategies for maintaining products on the market.
  • Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.
  • Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
  • Assess global impact of changes to launched products and support notifications/submissions as required.
  • Review labeling and marketing literature for compliance with regulatory requirements.

What you need

  • A Bachelor’s Degree (B.S or B.A) is required; Engineering, Science or equivalent focus is preferred.
  • A minimum of 7 years of experience in an FDA regulated industry required.
  • A minimum of 3 years of Regulatory Affairs experience required.
  • Knowledge of either US or EU regulatory requirements is required
  • Experience in authoring 510(k) or CE mark documentation is required.
  • Excellent analytical and writing skills.
  • Excellent interpersonal, written and oral communication skills.
  • Effective organizational skills.

 

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

 

APPLY NOW

Job posted: 2022-07-18