Principal Regulatory Affairs Project Manager, R&D

+ Plans, conducts and supervises assignments.
+ Reviews progress and evaluates results.
+ Recommends changes in procedures.
+ Operates with substantial latitude for un-reviewed action or decision.
+ Reviews progress with management.
+ Tasks may include:
+ Evaluation of regulatory risks of corporate policies.
+ Recruiting, development and mentoring of regulatory professionals.
+ Development of new regulatory policies, procedures and SOPs and training of key personnel on them.
+ Assisting in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization.
+ Utilization of technical regulatory skills to propose strategies on complex issues.
+ Monitoring emerging issues and identifying solutions.
+ Monitoring trade association positions for impact on company products.
+ Providing regulatory input to product lifecycle planning.
+ Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and developing solutions with other members of regulatory and related teams.
+ Evaluating the effect of regulatory requirements on product positions.
+ Assisting in the development of global, regional and multi-country regulatory strategy and updating strategy based upon regulatory changes.
+ Determining submission and approval requirements.
+ Monitoring regulatory outcomes of initial product concepts and provide input to senior regulatory management.
+ Assisting in regulatory due diligence.
+ Review and approve labeling to ensure compliance with regulations and company policy.
+ Develop, implement and manage appropriate SOPs and systems to facilitate R&D product lifecycle.
+ Providing strategic input and technical guidance on regulatory requirements to development teams.
+ Evaluating risk of and regulatory solutions to product and clinical safety issues during R&D phases and recommending solutions.
+ Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
+ Managing and executing preapproval submission activities.
+ Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval/clearance.
+ Identifying issues early in the submission preparation process that could impact product launch.
+ Monitoring impact of changing regulations, on submission strategies and update internal stakeholders.
+ Preparing regulatory submissions.
+ Works with minimal supervision and instruction of more experienced staff.
+ Must take a technical leadership role on one or more significant projects.
+ Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations.
+ Demonstrates developing leadership skills.
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer ? M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor?s legal duty to furnish information.
Stryker is one of the world?s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com

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