Stryker Senior Regulatory Compliance Specialist (Joint Replacement) in Mahwah, New Jersey
"Guide the division through post-market regulatory actions by managing the evaluation of potentially non-conforming product and driving organizational decision on product field actions through technical and medical assessments, as well as Health Hazard Evaluations. . Perform recall activities including collaborating with internal stakeholders, developing distribution and consignee reports, sending recall communications to internal and external potentially affected parties, and drafting, gathering and submitting all relevant documents to FDA. Address requests for information related to post market regulatory actions from Competent Authorities from around the world.,
5+ years of experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices. Experience in Health Hazard Evaluations, MDR/MDV reporting and product recalls.
Bachelor Degree required.
In-depth knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Marketing and Quality.
Demonstrated ability to lead key initiatives and priorities within the department and across various departments.
Demonstrated ability to mentor less experienced employees in the area of Health Hazard Evaluations, Recalls and addressing Competent Authority requests.
Proficient with Microsoft Office and ability to learn Corporate systems
Demonstrated interpersonal, written English and oral communication skills
Ability to interface with both technical and non-technical personnel at all organizational levels.
Ability to read and interpret Engineering schematics/drawing/prints
Demonstrated organizational, problem-solving, and analytical and time management skills
Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
Ability to work independently and to provide guidance to other functional experts
Demonstrated ability to exhibit a positive, energetic approach to teamwork.
Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.
Demonstrated 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.
Work From Home: No
Travel Percentage: None
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.
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