Manager, Regulatory Affairs - Fremont, CA - Stryker Corporation

Date de publication : 10/7/2019

Résumé de l'offre

Description de l'offre

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 Manager, Regulatory Affairs to join our Neurovascular Division to be located in Fremont, CA.

At Stryker Neurovascular, our mission centers on Complete Stroke Care which aims to reverse the trend of 120,000 – a staggering 1 in 20 – US deaths caused by over nearly 800,000 US strokes per year. We are the market leader in cutting edge, less invasive neuro-technologies that not only improved patient outcomes, but also led to double digit divisional and Stryker’s overall business growth. Our stent retriever technologies were proven with Class 1, Level A evidence to reduce death and disability in 5 recent, landmark clinical trials that spurred a major overhaul of the ASA/AHA Guidelines for treating acute ischemic stroke. In February 2019, Stryker Corporation (NYSE: SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. Watch this video to see how Stryker is making a difference:

Who we want

  • Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
  • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
  • Insightful advisors. Managers who lead strategy development and provide guidance to teams
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  •  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. 
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As the Manager, Regulatory Affairs you will manage regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc. Provide counsel to and manage the regulatory team. Ensure timely preparation of organized and scientifically valid applications. Provide expertise in translating regulatory requirements into practical, workable plans. Interact with regulatory agencies.

  • Manage development and implementation of regulatory strategies of RA staff for new and modified Class I, II and Class III devices through interface with FDA, Notified Body and other international authorities, and internal team members.
  • Assist with departmental policy and procedure development and implementation.
  • Develop personnel through daily interactions and coaching of staff, provide guidance to staff in technical and Regulatory matters and in effective business partnering with Marketing, R&D, and Clinical.
  • Provide regulatory affairs training to manufacturing and development teams.
  • Administer nonconforming materials and corrective action programs. 
  • Responsible for implementation of the internal and external audit programs required for compliance to domestic and international regulations & standards.

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) required; with a focus in a scientific or technical discipline preferred.
  • A minimum of 9 years of experience within regulatory medical device industry required.
  • RAPS certification preferred.
  • Progressive management experience required. 
  • Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US and EU Medicals Devices: IDE, PMA HDE, 510(k) and EU Design Dossiers required.
  • Strong technical knowledge of medical device products.
  • Comprehensive understanding of relevant medical procedures, practices, terminology, and products.
  • Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.
  • Thorough knowledge of product development process and design control.
  • Excellent research and analytical skills.
  • Excellent written and oral communication, technical writing and editing skills.
  • Ability to effectively manage multiple projects.
  • Strong organizational, leadership, interpersonal and influencing skills.

Work From Home: No

Travel Percentage: Up to 25%

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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