We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Joint Replacement Division based hybrid in Weston, FL or Mahwah, NJ.

Who we want

• 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.

• 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 support Stryker’s Joint Replacement Robotics and Digitial medical device hardware and software new product development and sustaining for both US and OUS Global Regulatory release by contributing to the development of regulatory strategy.

You will advise project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements. 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.

• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure
  product compliance

• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization 

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Provides regulatory input and technical guidance on global regulatory requirements to product development teams

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• Provides regulatory information and guidance for proposed product claims/labeling

• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

What you need

• Bachelor’s Degree (B.S or B.A) in Engineering, Science is required.

• 7+ years of experience in an FDA regulated industry required, preferably with medical devices.

• 3+ years of Medical Device Regulatory Affairs experience required.

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

• General understanding of product development process and design control.

• Thorough understanding of FDA and international medical device regulations.

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

• Previous experience drafting regulatory submissions required

• Experience interacting with regulatory agencies preferred.