Regulatory Specialist, Post Market Surveillance (Remote)

Work Flexibility: Remote

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

Who we want

• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams. 
• 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.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

We are currently seeking a Regulatory Affairs Specialist, Post Market Surveillance to join our Spine Division. This role will be based remotely anywhere in the United States.

What you will do

This position will be responsible for evaluating the reported events for reportability to FDA under MDR regulations and submit reports within specified timeframes. Assessing patient risk and associated harm in collaboration with engineers to accurately make reportability decision.

Develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures.

• Review and assess all incoming product complaints according to the regulatory requirements governing MDR, MDV, MDSAP Reporting to determine if the event meets reporting criteria.
• For reportable events, you will be expected to ensure reports are well-written and accurate 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
• Maintain systems to track, manage, and report product-associated events
• Maintain knowledge of applicable regulations in the US and OUS
• Responsible for addressing various inquiries from global Regulatory Agencies through direct communications and various regulatory audits.
• Participate and/or lead various projects and initiatives with the team as well as our cross-functional partners.
• Follow-up with Sales Reps and Hospitals to obtain applicable information pertaining to reported events as needed.
• Work closely with quality engineering and advanced quality engineering to assess patient risk, failure modes and associated harms within the complaint investigation to accurately assess reportability decisions.
• Responsible for compliance related non-conformances and CAPAs
• Prepare ad-hoc reports as required.
• Provide MAUDE database searches and reports as required.
• Participate in special projects and perform other miscellaneous duties as required.

What you need

• Bachelor’s Degree Required. Bachelor’s degree in engineering or science preferred.
• 0 – 2 years related work experience in an FDA or regulated industry required.
• 1+ years medical device or regulatory experience – preferred.
• Knowledge of FDA and international medical device regulations and standards (CFR, MDR, QSR, ISO 13485, MDSAP, etc.)- preferred.
• Medical device product experience preferred.

Travel Percentage: 10%

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, disabi