Senior Regulatory Affairs Specialist

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. More information is available at www.stryker.com

We are currently seeking a Senior Regulatory Affairs Specialist to join our Joint Replacement Division based Hybrid in Mahwah, New Jersey.

Who we want

• 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. 
• 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. 
• 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 Regulatory Affairs Specialist, you will support Stryker’s Joint Replacement implant and instrument portfolio change control process for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy driven by manufacturing, supplier, design, material, labeling changes. 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. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. You will work on a highly motivated global team supporting the cutting edge of orthopaedic solutions, to improve patient outcomes.

• Evaluates the regulatory environment and provides internal advice for proposed device changes to ensure product compliance.
• Supports a broad portfolio of orthopaedic implants and instruments across Stryker global manufacturing sites.
• Evaluates proposed design and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Collaborates with project teams, provides technical guidance and advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency.

What you need

• A Bachelor’s Degree (B.S or B.A) required; in Engineering, Science or equivalent focus preferred.
• A minimum of 3 years of experience in an FDA regulated industry required; preferably within medical devices.
• A minimum of 1 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.
• Understanding of FDA, Europe and international medical device regulations required.
• Previous experience with Class II/III medical devices preferred.
• Previous experience drafting 510(k)s and EU submissions 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.