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Regulatory Affair Manager in Fremont, CA at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

An Opportunity to Make a Difference in the World

If you’re a results-driven Regulatory Manager looking to make a difference in the world, consider why Stryker may be right for you:

  • Stryker is a Fortune 400 company and one of the world’s leading medical technology companies with 35 years of sales growth, nearly $10B annual sales and more than 26,000 employees working in 100+ countries.
  • Fortune Magazine has named Stryker a Most Admired Company in Medical Products and Equipment since 2005 and a Top 100 Places to Work for five consecutive years; #21 in 2016. We are 1 of only 5 companies awarded Gallup Great Workplace Award 7 or more times.
  • Our collective mission, together with our customers, we are driven to make healthcare better, and strong culture of innovation fuels our growth We hold over 5,300 patents in diverse field medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.

Stryker is a Fortune 400 company and one of the world’s leading medical technology companies with 35 years of sales growth, nearly $10B annual sales and more than 26,000 employees working in 100+ countries.

Responsibilities:

  • 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.

Experience Required:

  • Bachelor's Degree or equivalent work experience, preferably in a scientific or technical discipline.
  • 10 plus years Regulatory Affairs medical device industry experience.
  • 5 plus years managerial/supervisory experience, with 2 or more direct reports.
  • Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US and EU Class III Medicals Devices: IDE, PMA HDE, 510(k) and EU Design Dossiers.
  • 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.
  • Professional certification(s) desired.

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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