at Fresenius Kabi USA, LLC in Lake Zurich, Illinois, United States
Job Description
Job Summary
The Regulatory Affairs Specialist conducts, and/or facilitates Post Market Surveillance activities associated with EU 2017/745 (MDR) and Global Post Market regulatory requirements for MedTech Division. This includes other responsibilities including ensuring conformance/compliance to regulations and policies. Collaborates closely with key process stakeholders including but not limited to Global Product Management, Regulatory Affairs, Medical Affairs, R&D, Manufacturing, and Quality located in US and International regions.
Responsibilities
Responsible for the Post-Market Surveillance (PMS) system for assigned products in alignment with MedTech RA PMS organization and in accordance with Global SOPs. This shall include but is not limited to:
Coordination, preparation, and execution of product specific plans and reports
PMS Plans and Reports (PMS, Periodic Safety Update Reports (PSUR))
Post Market Clinical Follow-up (PMCF) Plans and Reports
Cross-functionally track and communicate PMS requirements/deliverables/data that are required to sustain ongoing PMS system compliance to key process stakeholders including risk management and clinical evaluation.
Support PMS/PMCF activities associated with other MedTech sites as needed.
Collaborates with the Global PMS Team to define the compliance strategies for post market surveillance requirements in alignment with local and international regulations, standards, and regulatory guidances. Identify and escalate issues from the post-market surveillance process and participate in resolution of escalated issues, as appropriate (e.g., Corrective and Preventive Actions)
Identify opportunities for improvement in documentation and collaborates in updating/creation of Global SOPs
Supports local regulatory and external audits
This job position within the Business Unit - Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).
Requirements
Bachelor's Degree preferred.
3 or more years in Quality/Clinical or Regulatory relevant experience.
Knowledge of applicable practices, regulations and standards related to Post Market Surveillance (e.g. FDA's 21 CFR part 820 (QSR), 21 CFR 803 (MDR), ISO 13485:2016, ISO 14971, MDD, EU MDR)
Regulatory response writing and audit experience preferred.
Ability to identify priorities to multiple high-risk projects and the ability to escalate in a timely manner to ensure the compliance with regulations and standard operating procedures.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.
Good interpersonal/influencing skills.
Expert understanding of product's intended use and manufacturing of assigned products. Readily accepting assignments to new/different products.
Excellent written/verbal communication and organizational skills.
Personal responsibility, organizational skills, communication, reliability, and good interpersonal skills
Ability to make independent decisions as well as ability to work in a team.
Excellent problem solving and analytical skills.
Excellent project management skills.
Strong Knowledge and application of computer skills for word processing, reporting metrics in Excel, etc (e.g., Word, SharePoint, PowerPoint).
Strong collaborator with cross functional teams and ability to interact effectively at all organizational levels and customers with ability to present ideas logically and concisely, both verbally and in writing.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
