Principal Regulatory Affairs Specialist, (Hybrid) - Michigan, Portage 1941 Stryker Way

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 www.stryker.com

We are currently seeking a Principal Regulatory Affairs Specialist to join our Instruments Division based Hybrid in Portage, Michigan.

Who we want

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the Principal Regulatory Affairs Specialist, you are a key expert, the job requires in-depth knowledge and understanding within one discipline. They are regarded within the organization as a technical 'expert' in their field. The job requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze, and validate potentially complex and dynamic material.

• Works with minimal supervision and instruction of more experienced staff
• Takes a technical leadership role on one or more projects of significance.
• Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations.
• Demonstrates developing leadership skills.
• Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
• Demonstrates strong technical and developing management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities, management and strategy.
• Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and management; monitoring and communicating change in the regulatory environment as well as global communication; staff and vendor development and management; and influencing the regulatory environment.
• Plans, conducts, and supervises assignments, reviewing progress and evaluating results.
• Recommends changes in procedures.
• Operates with substantial latitude for independent action or decision, and reviews progress with management.

What you need

• A Bachelor’s degree required; in Engineering, Biological Sciences or equivalent focus preferred.
• A minimum of 9 years of working in a FDA regulated industry required.
• A minimum of 7 years of Regulatory Affairs experience required.
• Previous experience authoring 510(k)s and other regulatory submissions required.
• Experience interacting with regulatory agencies required.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
• Strong leadership skills.
• Demonstrated success in management of global regulatory strategy and submission activities required.
• Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).
• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
• Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.
• Strong interpersonal, written, and oral communication skills.

Travel Percentage: 40%

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.