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Senior Regulatory Compliance Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 5/17/2019

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 a Senior Regulatory Compliance Specialist to join our Trauma and Extremities Division to be based in Mahwah, NJ.

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. 
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • 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 Senior Regulatory Compliance Specialist, you will assess 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.

  • Assures the company’s compliance with the FDA Medical Device regulations under 21 CFR 803 (MDR) and the European MEDDEV (MDV) requirements.
  • Assure public safety by identifying potential product problems and assuring they are promptly addressed.
  • Addresses inquiries from various Regulatory Agencies through direct communications and various audits.
  • Learn our Trauma and Extremities products through hands-on training and reading through surgical techniques. 

What you need

  • A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
  • A minimum of 3 years of experience analyzing Medical Device complaints and reporting on adverse events.
  • 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.

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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