Stryker Sr Regulatory Reporting Specialist in Mahwah, New Jersey
Requisition ID 26432BR
Job Title Sr Regulatory Reporting Specialist
Division Joint Replacement
Business Unit RCNCQR
Business Function Regulatory Affairs
Country United States
Employment Category Full Time
Percent Travel Required Up to 10%
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. We are an EO employer – M/F/Veteran/Disability.
Job Description / Information
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, European Competent Authorities, and BSI within strict time-lines. This critical function assures the company’s compliance with the FDA’s Medical Device regulations (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 team addresses inquiries from various Regulatory Agencies through direct communications and various audits.
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.
Review and approve regulatory filing decisions.
Interact with Regulatory Agencies to assure their questions are addressed within established time-frames
Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision
Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file
Act as mentor for less experienced employees in the area of adverse event reporting
Update current procedures/processes or create new procedures/processes
Work from verbal and/or written instructions
Track metrics on process timeliness and effectiveness
Participate and/or lead process improvement projects
Train and mentor new and/or less experienced employees as well as cross functional partners in the process
May provide adverse event reporting data for product recalls and recall communications.
3+ years experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices/Pharmaceuticals
Ideal candidate will demonstrate applied 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/MDV reporting
Demonstrated organizational, problem-solving, analytical and time management skills
Demonstrated interpersonal skills required to interface with technical and non-technical personnel at all levels of the organization
Demonstrated ability to effectively communicate through written and oral means on behalf of the department
Ability to respond to the urgent needs of the department as well as the ability and versatility to adapt to changing priorities.
Proven track-record for meeting deadlines and delivering results
Experience in technical/procedure writing is preferred
Demonstrated ability to exhibit a positive, energetic approach to teamwork.
Proficient with Microsoft Office and ability to learn Corporate systems
Proficiency with TrackWise is preferred.
Ability to read and interpret Engineering schematics / drawings / prints is preferred.
Positive, energetic approach to teamwork and an advocate for quality.
All 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