Staff Regulatory Compliance Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 2/7/2020

Job Snapshot

Job Description

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 an experienced Regulatory Compliance Specialist to join our Joint Replacement division to be based in Fort Lauderdale, FL or Mahwah, NJ.

Who we want

  • Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and 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. 
  • Communicators. Articulates well and expresses ideas effectively.
  • Learners. Great desire to learn and looks to continuously improve.
  • Teammates. Supports, encourages, and inspires others.

What you will do

As a Staff Regulatory Compliance Specialist, you'll be responsible for evaluating potential non-conforming product and driving organizational decision on product field actions through Health Hazard Evaluations. You will also evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities and perform recall activities including running distribution reports, sending recall communications to the field and gathering and submitting relevant documents to FDA. You will address requests for information from Competent Authorities and independently manage Post Market Regulatory projects.

​Essential Duties/Responsibilities:

  • Initiate Health Hazard Evaluation documents in document control system and assign to manufacturing location for substantial completion. 
  • Communicate potential actions to internal stakeholders.
  • Receive partially completed Health Hazard Evaluation documents from manufacturing location and coordinate action decision at divisional level.  Complete Health Hazard Evaluation documents.  Manage approval process for rapid decision making and action. 
  • Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities. 
  • Ensure reports to FDA / Competent Authorities are completed within required timelines.
  • Request information from the field to ensure all pertinent information is acquired to make adequate MDR/MDV decision.
  • Submit initial and follow-up reports to device related Agencies as appropriate
  • Interact with device related Agencies on vigilance reports and incidents
  • Work with Quality complaint-handling personnel
  • Review and analyze data for trending purposes
  • Work from verbal and/or written instructions.
  • Initiate and lead cross-department teams on gathering information and strategizing replies to requests for additional information from CAs within required time deadlines.
  • Lead key initiatives and priorities with the department including drafting of HHE, managing recalls, addressing CA requests and adverse event reporting.
  • Act as mentor for less experience employees in the department in the areas of HHE, recalls, CA requests and adverse event reporting.
  • Draft recall communication to field and coordinate any other communication that Marketing may want to make in conjunction with field actions.
  • Communicate recalls to FDA within 10 days of decision.  Gather, organize and submit all relevant recall documentation to FDA.  Submit recall communication to FDA District office and receive approvals.
  • Manage and oversee recall communications with FDA including any additional information FDA requests in classification letters or closure letters.
  • Oversee reporting of recall effectivity to corporate entities.
  • Drive timely recall closure by coordinating resources and product disposition in conjunction with management.
  • Develop and execute process and product protocols and reports
  • Develop statistical process controls and data analysis tools
  • Track metrics on process timeliness and effectiveness.
  • Lead and manage process improvement and automation.

What you need

  • Bachelor’s Degree in Science, Engineering or related field of study
  • 5+ years of experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices
  • Experience in Health Hazard Evaluations, MDR/MDV reporting and product recalls
  • In-depth knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
  • Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Marketing and Quality
  • Demonstrated ability to independently lead key initiatives and priorities within the department and across various departments
  • Demonstrated ability to mentor less experienced employees in the area of Health Hazard Evaluations, MDR/MDV reporting, Recalls and addressing Competent Authority requests
  • Proficient with Microsoft Office and ability to learn Corporate systems
  • Demonstrated interpersonal, written English and oral communication skills
  • Ability to interface with both technical and non-technical personnel at all organizational levels
  • Ability to read and interpret Engineering schematics/drawing/prints
  • Demonstrated organizational, problem-solving, and analytical and time management skills
  • Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
  • Ability to work independently and to provide guidance to other functional experts
  • Demonstrated ability to exhibit a positive, energetic approach to teamwork
  • Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality
  • Demonstrated results orientation and ability to learn quickly
  • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines

Work From Home: Occasional

Travel Percentage: 20%

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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