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Post Market Regulatory Compliance Specialist (R468322)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Mahwah, New Jersey, United States

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.


Stryker is seeking a Post Market Regulatory Compliance Specialist for our Trauma & Extremities division to be based hybrid in Mahwah, NJ or Memphis, TN.

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, information, use cases, and industry analyses to develop best practices.

  • 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 Post Market Regulatory Compliance Specialist, you will review and assess all incoming product complaints according to the regulatory requirements governing FDA MDR and EU Vigilance reporting to determine if the event meets reporting criteria. For reportable events, you will be expected to ensure reports are well-written and submitted to the applicable agency within the required timeframes. For events that do not meet reporting criteria, you will utilize data from risk table documentation and/or liaise with clinicians and subject matter experts to compose a comprehensive rationale for not reporting the event to Regulatory Agencies. Additionally, you will be responsible for addressing various inquiries from global Regulatory Agencies through direct communications and various regulatory audits. To ensure continuous process improvement and efficiency, you will also be expected to participate and/or lead various projects and initiatives with the team as well as our cross-functional partners.

Key Areas of Responsibility:

  • Regulatory review of product complaints to determine adverse event reportability

  • Perform adverse event filings, including MDR and MIR reports

  • Review complaints for adequate closure

  • Research potential injury liability issues

  • Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions.

  • Utilize risk management process to determine potential and actual risk related to complaint events.

  • Work with senior staff to respond to additional Information requests from Global Regulatory Agencies

  • Review and input into standard operating procedures (SOPs)

  • Maintain compliance to regulations

  • Communicate with Global RAQA on complaint investigation or recall instructions

  • Provide correspondence to regulatory agencies under close supervision

  • Provide regulatory compliance guidance and/or training to others

  • Participate in internal regulatory and quality audits as assigned

  • Communicate with internal and external resources globally

  • Ensure complaints are classified correctly and that all supporting data for investigations are adequately documented and attached to the complaint file

  • Identifying product-associated problems and assist in developing proposals for solutions

  • Assisting in SOP development and review

  • Evaluating regulatory impact of proposed changes to launched products

  • Monitoring impact of changing regulations

  • Reviewing publicly disseminated information to minimize regulatory exposure

What you need

  • Bachelor’s degree required

  • Minimum 2 years of work experience within regulatory affairs or quality

  • Experience in technical/procedure writing

  • Experience analyzing Medical Device complaints and reporting on adverse events


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