Regulatory Compliance Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 8/14/2019

Job Snapshot

Job Description

Who we want

  • Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.
  • Achievers. Thrives on accomplishing tasks and constantly driven to do more.
  • Collaborators. Collaborates and builds relationships with internal and external stakeholders.
  • Communicators. Articulates well and expresses ideas effectively.
  • Teammates. Supports, encourages, and inspires others.

What you will do

The Regulatory Reporting team assesses all incoming product complaints to identify adverse events (deaths or serious injuries) or situations (device malfunctions/use errors) that may result in adverse events and submit reports to FDA and European Competent Authorities within strict time-lines. This critical function assures the company’s compliance with the FDA Medical Device regulations under 21 CFR 803 (MDR) and the European MEDDEV (MDV) requirements as well as assuring public safety by identifying potential product problems and assuring they are promptly addressed. Additionally, the Regulatory Reporting responsibility addresses inquiries from various Regulatory Agencies through direct communications and various audits. Responsibilities include:

  • Learn Stryker's Trauma and Extremeties products through hands-on training and reading through surgical techniques.
  • Evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities. 
  • Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities
  • Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
  • Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision.
  • Support interactions with Regulatory Agencies as required.
  • May aid in updating current procedures/processes or assist in creating new procedures/processes.
  • Review and analyze data for trending purposes
  • Work from verbal and/or written instructions.
  • Track metrics on process timeliness and effectiveness.
  • Participate in Post-Market Compliance initiatives.

What you need

  • Bachelor's degree
  • 1-3 years of experience as a Regulatory or Quality professional in a regulated manufacturing environment
  • Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements
  • Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive, 21CFR820 (QSR)/803(MDR), MEDDEV 2.12-1(Guidelines on Medical Device Vigilance System), etc.)
  • Adaptable to a fast paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamically thriving environment
  • Strong interpersonal, written and oral communication skills
  • Proven ability to communicate with Salespersons and other key field personnel
  • Good time and project management skills with the ability to multi-task

You may also have

  • 2+ years’ experience in an FDA regulated medical device environment
  • Experience with MDR/MDV reporting
  • Masters or advanced degree

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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