Senior Manager, Regulatory Affairs in Kalamazoo, MI at Stryker Corporation

Date Posted: 11/27/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Manager, Regulatory Affairs to join our Medical Division to be based in Kalamazoo, MI.

Who we want

  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

  • Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members. 

  • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

What you will do

As the Senior Manager, Regulatory Affairs, you will be responsible for providing leadership, organization and coordination of the Medical Division’s global regulatory strategies and submissions to support high impact product launches and ongoing market access. You will confidently and collaboratively work across the RA team and cross-functional partners as well as with individuals across international locations and time zones, cultures and languages to support International Division sales growth. In addition, you will lead the team to drive global standards within product design and provide regulatory guidance on international markets.

  • Lead advocacy activities of a more advanced and global strategic nature.     

  • Develop and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies.

  • Analyze the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.

  • Assess 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 assess the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.

  • Negotiate with regulatory authorities on complex issues throughout the product lifecycle.

  • Establish working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.

  • Identify the need for and manages the development and execution of new regulatory procedures and standard operating procedures.

  • Develop and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

  • Provide regulatory guidance on strategy for proposed product claims/labeling.

  • Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions.

  • Lead key negotiations and interactions with regulatory authorities during all stages of the development and review process.

  • Prepare 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.

  • Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.

  • 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.

  • Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature.

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) required; preferably in Science or Engineering.

  • A minimum of 10 years of experience within a regulated industry required; preferably in Medical Device.

  • A Master’s Degree or advance degree preferred​.

  • A RAC Certification preferred.

  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements required.

  • Demonstrated technical knowledge of medical device product line required.

  • 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 preferred.

  • Demonstrated leadership skills.

  • Demonstrated process improvement and management skills.

  • Experience with recruiting employees preferred.

  • Experience in managing a team of direct reports including people development required.

Work From Home: Occasional

Travel Percentage: 20%

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.

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