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Medical Device Regulatory Affairs Coordinator

3 months ago

Harleysville, United States Medical Components Full time

This is an onsite position, 5 days a week, in Harleysville, PA. Only candidates within driving distance (1hr) will be considered. Qualifications - A.A. or bachelor's degree (B.A./B.S.) from four-year college or university. At minimum 0+ years related experience and/or training, or equivalent combination of education and experience. Prior knowledge of Regulatory Affairs and/or Medical Devices is a plus RAC Certification preferred. Knowledge of Lean manufacturing and Six Sigma are preferred. What you will be responsible for: The Regulatory Coordinator assists Regulatory Specialist with compiling documentation, providing guidance, strategy, communication, writing, and/or filing submissions to global regulatory bodies to support new product development and/or sustaining product that require regulatory approval and/or clearance. Essential Duties and Responsibilities include the following. Other duties may be assigned. May manage minimal products as assigned by department management. Act as the Regulatory subject matter expert of the assigned product(s) and provide regulatory support pertaining to the product(s) with the additional guidance of Regulatory Specialist and/or department management. Develop an understanding of global medical device regulations in which the organization intends to obtain marketing clearance/approval of product(s) for commercial distribution. Under the supervision of a Regulatory Specialist and/or Department Management, provide regulatory strategy for sustaining product projects and/or new product development project as assigned. This includes documenting testing requirements, submission/registration pathways, and anticipated approval/clearance timelines for defined target markets. Under the supervision of a Regulatory Specialist and/or Department Management, provide support in writing submissions, design dossiers, technical files as required by global medical device regulations to obtain product clearances and or approvals for commercial distribution within targeted selling market. Provide support in writing change notifications and/or amendment to existing product clearances and/or approvals. Responsible for assigning, implementing, and maintaining global Unique Device Identifier (UDI), GTINs, and GMDN codes. Compile documentation included test protocols and reports, drawings, specifications, etc. to complete a regulatory submission, registration, etc. as required by the intended global medical device regulation in which product clearance and/or approval for commercial distribution is intended. This requires cross functional departmental interaction and communication. Obtain and compile documents such as Certificate to Foreign Government/Free Sales, and/or Certificate of Exportability. This includes any required notarizing and/or legalization of documents Under the supervision of a Regulatory Specialist and/or Department Management, support the submission process for completed submission, registrations, application, change notification, or amendments to global regulatory authority in which clearance and/or approval for commercial distribution is intended. Under the supervision of a Regulatory Specialist and/or Department Management, support the partnership with global regulatory contacts to understand requirements for product registration for new and/or modified products. Strategize, develop, and submit product registrations and/or applications for new and/or modified products. Maintain all communication and correspondence with all regulatory authorities pertaining to regulatory submission including, but not limited to, submissions, registration, applications, change notifications, or amendments. Organize and file the documentation within department network drive and as directed by department management. Contribute to the maintenance of all regulatory certifications, approvals, clearances, registrations, application, etc. in accordance with the QMS documentation retention process. Contribute to the traceability of certification/registration/licenses expiration dates and ensure appropriate renewal commences. Work in partnership with other departments (i.e., engineering, quality, manufacturing, sales, marketing, etc.) to support regulatory submissions and/or ensuring regulatory compliance. Perform routine review of regulatory standards and guidance documents to ensure continued compliance with regulations and standards against the Quality Management System and medical device performance. Participates in change control processes (CRs, AMVs, VARs, SCRs, NCRs, CAPAs, etc.) that impact the assigned product(s). Perform change assessment analysis and, when appropriate, approve on behalf of Regulatory Affairs. Under the supervision of a Regulatory Specialist and/or Department Management, notify distributors, regulatory bodies, and/or other marketing authorization holders of significant changes considered to impact existing registrations, clearances, approvals, licenses, etc., as appropriate. Work with in-country partners to complete notifications, amendments, and registration renewals as required Support and assist with internal and/or external Quality Management System audits as required. This may include performing Corrective and Preventative Actions initiated by an audit finding, that is respective to regulatory processes. Develop, implement, and maintain regulatory affairs department responsibilities, procedures, and processes within Medcomp Quality Management System. Support regulatory training to the organization as necessary for continued regulatory compliance. Support internal and external global regulatory requests. Ensure a professional working relationship with internal and external customers to achieve success. About Us - Medcomp® develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies. Our offerings have our Team Members well-being in mind. Competitive compensation Health, Dental, Vision coverage FSA Life Insurance 401k Paid Holidays Generous PTO What you will get from us: VISION & MISSION STATEMENT To be the leading solution provider for every customer we serve. To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services. We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed. We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.