Post Market Regulatory Compliance Specialist - Portage, MI - Stryker Corporation

Date de publication : 11/15/2019

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 Post Market Regulatory Compliance Specialist to join our Instruments Division to be based in Portage, MI.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 
  • 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. 

What you will do

As the Post Market Regulatory Compliance Specialist, you will review and assess all incoming product complaints according to the regulatory requirements governing MDR and/or MDV Reporting to determine if the event meets reporting criteria. For reportable events, you will be expected to ensure reports are well-written and submitted to the applicable agency within the required time-frames. For events that do not meet reporting criteria, you will utilize data from risk table documentation and/or liaise with clinicians and subject matter experts to compose a comprehensive rationale for not reporting the event to Regulatory Agencies. Additionally, you will be responsible for addressing various inquiries from global Regulatory Agencies through direct communications and various regulatory audits. To ensure continuous process improvement and efficiency, you will also be expected to participate and/or lead various projects and initiatives with the team as well as our cross-functional partners.

  • Review complaints for adequate closure.
  • Review labeling and literature for regulatory concerns.
  • Research potential injury liability issues.
  • Decide when a nonconforming event has occurred and originate nonconformances into eCAPA system.
  • Customer follow up for missing information in complaint files and ensure product returns for analysis.
  • Monitor and facilitate product return for complaint investigation and analysis.
  • Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions.  
  • Perform adverse event filings, including MDR and MDV reports.
  • Utilize risk management process to determine potential and actual risk related to complaint events.
  • Work with senior staff to respond to Additional Information requests from Global Regulatory Agencies.
  • Analyze complaint information to identify similar events or failure modes.
  • Review and input into SOPs.
  • Maintain compliance to regulations.
  • Provide input for product recalls and recall communications.
  • Execute recall communications internally and externally.
  • Witness destruction of nonconforming product.
  • Maintain quarantine of recalled or nonconforming product.
  • Communicate with Global RA/QA on complaint investigation or recall instructions.
  • Track and report on recall progress and completion.
  • Provide correspondence to regulatory agencies under close supervision.
  • Provide regulatory compliance guidance and/or training to others.
  • Perform internal regulatory and quality audits as assigned.
  • Determine product failure root causes and evaluate risk of failures.
  • Investigate related failures, design, and manufacturing history of failed devices.
  • Determine trend results to input into post market product failure data.
  • Communicate with internal and external resources globally.
  • Ensure complaints are classified correctly and that all supporting data for investigations are adequately documented and attached to the complaint file.
  • Identifying product-associated problems and assist in developing proposals for solutions.
  • Assisting in SOP development and review.
  • Evaluating regulatory impact of proposed changes to launched products.
  • Monitoring impact of changing regulations.
  • Reviewing publicly disseminated information to minimize regulatory exposure.

What you need

  • A minimum of a bachelor’s degree (B.S. or B.A.) required.
  • A minimum of one year of relevant work experience required.
  • Previous Regulatory or Quality experience preferred.
  • Knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization), etc. preferred.
  • Experience with MDR/MDV reporting preferred.
  • Experience analyzing Medical Device complaints and reporting on adverse events preferred.
  • Experience in technical/procedure writing is preferred.
  • Proficient with Microsoft Office and ability to learn Corporate systems required.
  • Ability to read and interpret Engineering schematics / drawings / prints is preferred.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Demonstrated organizational, problem-solving, analytical and time management skills.
  • Demonstrated interpersonal skills required to interface with technical and non-technical personnel at all levels of the organization.

Work From Home: Occasional

Travel Percentage: 0%

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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