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Senior Regulatory Affairs Specialist in Fremont, CA at Stryker Corporation

Date Posted: 2/14/2019

Job Snapshot

Job Description

Under direct supervision of the RA Manager.

  • Assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as:  IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, HDE, HDE Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical File, Intercontinental Dossiers and Certificates to Foreign Government.  Ensures that existing approvals and documentation are maintained.  Communicates with in-country RA personnel to facilitate global clearances/approvals.*
  • Develops global regulatory strategies for project teams.  Provides input on and reviews protocols and reports for:  design verification, design validation, shelf life, pre-clinical studies, and clinical studies.  Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors. *
  • Communicates with regulatory agencies under direct supervision of the RA Project Manager or RA Department Manager. *
  • Evaluates proposed changes to products and controlled documents; recommends and implements global regulatory action plans based on changes.  Organizes and maintains RA files. *
  • Reviews labeling (Instruction for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations and regulatory approvals/clearances. *
  • Assists in performing basic to moderately complex research to support strategic planning. *
  • Provides regulatory support to other Stryker and Stryker Personnel to facilitate cross-divisional leverage.
  • Understands: Stryker Neurovascular systems, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.
  • Analyses existing systems and procedures, recommends solution/improvements, and writes Work Instructions and SOPs, as needed to support departmental functions and Stryker Neurovascular Quality System.
  • Uses existing project management tools.
  • May mentor others on an infrequent basis.  Is not expected to supervise others.
  • Performs responsibilities required by the Quality System and other duties as assigned or requested.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).

* Indicates Essential Function

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Work From Home: Yes

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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