Job Details
Stryker
MDR/Vigilance Specialist (Remote)
COVID-19 vaccination requirements
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.
Why join Stryker?
We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
Why regulatory affairs/quality assurance at Stryker?
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
We are currently seeking a MDR/Vigilance Specialist to join our Trauma and Extremities Division to be based in Mahwah, NJ, Memphis TN, or remotely 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.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
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 an MDR/Vigilance 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.
Electronically process customer complaints to determine adverse event reportability.
Complete electronic submission of MDRs and MIRs 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.
Review and input into standard operating procedures (SOPs).
Maintain compliance to regulations.
Provide correspondence to regulatory agencies under close supervision.
Participate in 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.
Monitoring impact of changing regulations.
What you need
A minimum of a Bachelor’s Degree (B.S. or B.A.) required.
A minimum 1 year of experience as a Regulatory or Quality professional in a regulated manufacturing environment is preferred.
Experience with Post-Market MDR/MIR reporting is desirable.
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/MIR reporting preferred.
Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing and Quality.
Demonstrated problem-solving and troubleshooting skills.
Demonstrated ability to exhibit a positive, energetic approach to teamwork.
Proficient with Microsoft Office and ability to learn Corporate systems.
Demonstrate interpersonal, written English and oral communication skills.
Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.
Demonstrate 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.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com