- Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
- Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
- Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
- Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
- Assesses links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.
- Participates in advocacy activities of a more advanced strategic nature.
- Develops and updates global, regional, and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies.
- Provides guidance to integrate regulatory considerations into global product entry and exit strategy.
- Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.
- Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
- Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles.
- Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.
- Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
- Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
- Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
- Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures.
- Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Provides strategic input and technical guidance on global regulatory requirements to product development terms.
- Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
- Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.
- Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.
- Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
- Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.
- Provides regulatory guidance on strategy for proposed product claims/labeling.
- Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
- Manages electronic (eCTD) and paper registration development.
- Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
- Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
- Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees.
- Manage day-to-day regulatory processes to ensure issues are appropriately evaluated.
- Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.
- Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
- Serve as Subject Matter Expert for regulatory processes.
- Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
- Establish standard process to ensure appropriate resolution and management of the responsible task owner.
- Chair meetings required to drive closure of regulatory issues.
- Manage and provide updates for regulatory metrics. Implement appropriate enhancements.
- Represent regulatory processes during internal and external audits.
- Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
- Recruit, select, and on-board top talent.
- Develop talent within team to increase performance. Actively address performance issues on team.
- Maintain a high level of team engagement.
- Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature.
- Bachelors in a science, engineering or related Advanced degree preferred.
- Minimum of 9 years' experience required.
- Minimum of 6 years' medical device experience required.
- Master's Degree or equivalent preferred.
- RAC desired
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements.
- Demonstrate technical knowledge of medical device product lines.
- Demonstrated written, verbal, listening, communication, and team building skills.
- Demonstrated ability to collaborate effectively with and lead cross-functional teams.
- Demonstrated ability to effectively prioritize and manage multiple project workloads.
- Demonstrated experience with trending and analysis reporting.
- Demonstrated leadership skills.
- Demonstrated process improvement and management skills.
- Experience with recruiting, people development.
- Influence across the organization.
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Manager, Regulatory Affairs - Minneapolis, United States - Stryker
Description
Work Flexibility: Hybrid
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at
Who we want
What you will do
The Manager, Regulatory Affairs (RA) works with a high level of autonomy to oversee the regulatory process for products requiring governmental approval, including filing necessary applications and handling government interactions to bring medical devices to market and ensure ongoing compliance while managing a regulatory team.
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.
Manager, Regulatory Affairs professionals in Minneapolis
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