Principal Regulatory Affairs Specialist (Hybrid)

Stryker is hiring a Principal Regulatory Specialist (Hybrid) in Columbia City Indiana. As part of the Trauma & Extremities Division you will play a key role in supporting the regulatory lifecycle of orthopedic implants and instruments designed for trauma and extremity procedures.

What you will do

• Assess global trends stakeholder concerns and regulatory issues to inform strategy.
• Develop and update global and regional regulatory strategies aligned with business goals.
• Identify and evaluate regulatory pathways for new product designs and market access.
• Analyze the impact of changing regulations on pre- and post-approval strategies.
• Incorporate expedited regulatory strategies for products addressing serious conditions or unmet needs.
• Negotiate with regulatory authorities throughout the product lifecycle.
• Establish and maintain relationships with government and non-government organizations affecting market access.
• Develop and manage regulatory procedures SOPs and training programs for compliance.
• Provide strategic input and technical guidance to product development teams.
• Evaluate clinical and manufacturing changes for regulatory filing requirements.
• Review and assess regulatory submissions clinical plans and product claims.
• Ensure clinical and nonclinical data support proposed product claims and labeling.
• Manage electronic (eCTD) and paper registration development and submission processes.
• Lead internal review and approval processes for regulatory submissions.
• Prepare cross-functional teams for regulatory interactions including advisory committees.

What you need

• Bachelors degree in engineering Science or related field.
• A minimum of 9 years of experience in an FDA regulated industry required; preferably with medical devices.
• A minimum of 7 years of Medical Device Regulatory Affairs experience required.

Preferred

• Masters degree in Regulatory Science or RAC certification.
• Experience with strategic regulatory planning and global submissions.
• Expertise in ISO standards and regulatory frameworks for medical devices.
• Articulates the organizations strategic vision in a manner that enables others to execute plans tactics and actions.
• Leverages a well-grounded knowledge of applicable laws regulations and policies to develop and execute plans and programs.
• Demonstrates the ability to build agreement and acceptance through presenting a compelling case for ideas negotiating persuasively and addressing disagreements constructively