Staff Regulatory Affairs Specialist in San Jose, CA at Stryker Corporation

Date Posted: 9/10/2018

Job Snapshot

Job Description

General Responsibilities:

  • Works under general supervision and instruction of more experienced staff
  • Reports observations/ problems clearly and concisely and takes appropriate actions
  • Demonstrates developing of advanced technical leadership skills within the department
  • Possesses and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Demonstrates strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
  • Demonstrates knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance
  • Plans, conducts and executes assignments, reviewing progress and evaluating results
  • Recommends changes in procedures when indicated
  • Operates with appreciable latitude for independent action or decision, and reviews progress with management
  • May direct work of Specialist or Sr. Specialist

TASKS may include:

  • Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government
  • Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval,
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes
  • Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
  • Advise responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Coordinate and execute preapproval compliance activities
  • Determine and communicate submission and approval requirements
  • Identify issues early in the submission preparation process that could impact product launch
  • Participate in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance
  • Monitor applications under regulatory review
  • Determine trade issues to anticipate regulatory obstacles
  • Provide regulatory input to product lifecycle planning
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Evaluate regulatory impact on proposed products
  • Provide input on and review protocol and reports for design verification and validation 
  • Participate in risk-benefit analysis for regulatory compliance
  • Participate in design reviews of products under development
  • Responsible for product release approval
  • Maintaining regulatory paper and electronic files
  • Review of advertising and promotional items
  • Review collateral material associated with new launches and ongoing product support
  • Assist in SOP development and review

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.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team