Regulatory Affairs Specialist

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 Regulatory Affairs Specialist to join our Joint Replacement Division to be based in Mahwah, NJ.

WHO DO WE WANT:

• 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.

• Self-directed innovators. 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.

WHAT YOU WILL DO:

We are looking for a collaborative team player who is interested in sustaining products on the global markets. As the Regulatory Affairs Specialist, you will develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures. You will work with supervision to ensure continued market assess and ongoing regulatory compliance of Stryker’s Joint Replacement implant and instrument portfolio in US and international markets. You will support the gathering of regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will support the execution of post market product lifecycle management.

• Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products

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

• Monitor and evaluate medical device regulation changes and develop and execute strategies for maintaining products on the global market.

• Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines

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

• Assess the acceptability of quality, preclinical, and clinical document in regulatory submissions to ensure compliance with applicable regulations.

• Review labeling and marketing literatures for compliance with regulatory requirements.

• Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Assess global impact of changes to launched products and support notifications/submissions as required

• Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support

• Support product life cycle management activities.

• Assist in the development and update of divisional regulatory procedures and SOPs to ensure regulatory compliance

• Self-direct work under general supervision. Review progress with management.

WHAT YOU NEED:

• Bachelor’s Degree required. Bachelor’s Degree in Engineering or Science preferred.

• 0+ years of experience in an FDA regulated industry, preferably within medical devices.

• 1+ years regulatory affairs work experience or regulatory internship preferred.

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

• General understanding of FDA and international medical device regulations preferred.

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

• Previous experience drafting/authoring regulatory submissions for product approval preferred.

• Experience interacting with regulatory agencies preferred.

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/