Principal Regulatory Affairs Specialist

Stryker Corporation Helena , MT 59624

Posted 2 weeks ago

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 Principal Regulatory Affairs Specialist to join Stryker's Instruments division based in Portage, Michigan or remotely anywhere within the United States. To learn more about the division, visit: [ Link removed ] - Click here to apply to Principal Regulatory Affairs Specialist

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.

  • Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

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

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • 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.

  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do

As a Principal Regulatory Affairs Specialist, you support global new product development regulatory release by developing and updating regulatory strategy. You support the product lifecycle through obsolescence by assessing changes made to the device post-launch to determine regulatory impact of changes to the current clearance. You also ensure regulatory compliance by completing through assessments and the appropriate submissions pertaining to product clearances or approvals by FDA, Notified Bodies and other regulatory bodies. In this role, you are the Stryker Instruments division subject matter expert for the regulatory and business requirements. You are actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business and organizational activities, management and strategy.

Responsibilities may include:

  • Providing strategic input and technical guidance on regulatory requirements to develop teams

  • Evaluating risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommending solutions

  • Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies; Managing and executing preapproval compliance 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 the impact of changing regulations on submission strategies and updating internal stakeholders

  • Prepare regulatory submissions and proposing risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment

  • Maintaining annual licenses, registrations, listings and patent information

  • Ensuring compliance with product post-marketing approval requirements

  • Reviewing and approving labeling, advertising and promotional materials to ensure compliance with regulations and company

  • Reviewing publicly disseminated information to minimized regulatory exposure, review product claims and preserve confidentiality of applicable product information

  • Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations

  • Providing regulatory input and appropriate follow-up to inspections and audits

  • Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events

  • Submitting and reviewing change controls to determine the level of change and consequent submission requirements

What you need

  • Bachelor's degree (BS or BA) in Engineering, Science, Regulatory or equivalent focus

  • Minimum 9 years professional experience with at least 5 years direct regulatory affairs experience within the medical device industry

  • Expert knowledge of medical device regulations with an emphasis on FDA and leading regulatory strategy

  • Demonstrated understanding of the FDA device listing and establishment registration process

  • Viewed as an expert in regulatory matters

  • Effective communicator and consensus-builder

  • Proven ability to implement large-scale projects on a broad scale

You may also have

  • Advanced degree; Masters in Regulatory Affairs

  • Regulatory Affairs Certification (RAC) or applicable professional certification

  • Prior divisional or cross-site experience

Work From Home: Remote

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.

Job Requirements

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Principal Regulatory Affairs Specialist

Stryker Corporation