Staff Specialist, Regulatory Affairs in Kalamazoo, MI at Stryker Corporation

Date Posted: 7/30/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Kalamazoo, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/30/2018
  • Job ID:
    R401722

Job Description

The Staff Specialist, Regulatory Affairs supports new product development for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Viewed as a departmental resource.


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:   

  • Assisting in SOP development and review
  • Assisting in the development and update of regulatory strategy based upon regulatory changes
  • Providing regulatory input new product development and product lifecycle planning
  • Evaluating regulatory impact of proposed changes to launched products
  • Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
  • Determining and communicating submission and approval requirements
  • Participating in risk-benefit analysis for regulatory compliance
  • Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions

Additional tasks may include:  

  • Maintaining annual licenses, registrations, and listings
  • Reviewing regulatory aspects of contracts
  • Ensuring compliance with product post-approval or clearance requirements
  • Approving labeling, advertising and promotional items for compliance before release
  • Reviewing publicly disseminated information to minimize regulatory exposure
  • Reviewing product claims and preserving confidentiality of applicable product information
  • Providing regulatory input for and appropriate follow-up to inspections and audits
  • Assisting in the development and implementation of SOPs and systems to track and manage product-associated events
  • Reviewing change management to determine the level of change and potential submission requirements
  • Identifying product-associated problems and developing proposals for solutions
  • Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
  • Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
  • Monitoring impact of changing regulations on submission strategies
  • Identifying issues early in the submission preparation process that could impact product launch
  • Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
  • Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance

Qualifications:

  • B.A. or B.S.in Science, Legal, Regulatory or Engineering, or equivalent
  • RAC certification or applicable professional certification (preferred)
  • Excellent analytical and writing skills
  • Effective interpersonal communication skills
  • Effective organizational skills
  • Advanced PC skills
  • Previous experience in legal, technical or a regulated environment
  • 4-6 years applicable experience

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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