Job Description

Stryker is one of the worlds 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 Stryker in Mahwah, New Jersey or remotely anywhere within the United States.

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, information, use cases, and industry analyses to develop best practices.
* 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 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 timeframes. 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.

Responsibilities include:

* Regulatory review of product complaints to determine adverse event reportability
* Perform adverse event filings, including MDR and MIR reports
* Review complaints for adequate closure
* Research potential injury liability issues
* Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions.
* 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
* Review and input into standard operating procedures (SOPs)
* Maintain compliance to regulations
* Communicate with Global RAQA on complaint investigation or recall instructions
* 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
* 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

* Bachelors degree required
* Minimum 2 years of regulatory or quality work experience
* 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.
* Experience with MDR/MIR reporting
* Experience analyzing Medical Device complaints and reporting on adverse events
* Experience in technical/procedure writing
* Ability to read and interpret Engineering schematics/drawings/prints
* Ability to understand and explain detailed regulatory compliance programs or issues
* Ability to comply with constantly changing regulatory procedures and prioritize work effectively