Stryker Group
Principal Regulatory Affairs Specialist (Hybrid)
Stryker Group, Columbia City, Indiana, United States, 46725
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
Bachelor’s 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 Master’s 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 organization's 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
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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
Bachelor’s 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 Master’s 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 organization's 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
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