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Senior Post Market Reporting Specialist in Fort Lauderdale, FL at Stryker Corporation
at Stryker Corporation
Stryker is one of the world’s 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 Post Market Reporting Specialist to join our Joint Replacement Division to be based in Fort Lauderdale, FL.
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 imitators. 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 the Senior Post Market Reporting Specialist, you will review and assess all incoming product complaints according to the regulatory requirements governing MDR and/or MDV 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 time-frames. 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.
- 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.
What you need
- A minimum of a Bachelor’s Degree (B.S. or B.A.) required.
- A minimum of 3 years of experience in a Regulatory or Quality position in a regulated manufacturing environment required; preferably in Medical Devices/Pharmaceuticals.
- 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/MDV reporting preferred.
- Experience analyzing Medical Device complaints and reporting on adverse events preferred.
- Experience in technical/procedure writing is preferred.
- 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.
- 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.
- Demonstrated ability to exhibit a positive, energetic approach to teamwork.
- Positive, energetic approach to teamwork and an advocate for quality.
Work From Home: No
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, 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.