Principal Regulatory Affairs Specialist (Remote)

Work Flexibility: Remote

We are currently seeking a Principal Regulatory Affairs Specialist to join our Instruments Division to be based in Portage, MI or remotely anywhere in the United States.

Who we want

• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

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

• Assess links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements and the implication for regulatory strategy

• Participates in advocacy activities of a more advanced strategic nature  

• 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

What you need

• BS Degree in Engineering, Science, or related required

• MS in Regulatory Science or Advanced degree desired

• RAC(s) desired

• Minimum 9 years of experience in medical device regulatory and/or clinical affairs required

$112,800.00 - $239,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 30%

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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