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Regulatory Affairs Specialist
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Company Name: Freudenberg Medical, Freudenberg Medical, formerly Freudenberg Medical and MedVenture, is a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services., For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Costa Rica, Europe and Asia., We are currently hiring for a Regulatory Affairs Specialist who is: Driven and focused on ensuring regulatory compliance for market-released products to ISO 13485/FDA & EU standards. Assists with the analysis, oversight, and verification of the Quality Systems and maintaining compliance to all applicable regulatory requirements. Self-motivated and thrives in a fast paced, team-driven, lean systems environment, where every day brings new projects and challenges., Basic Responsibilities Assists in the completion and assembly of regulatory submissions (both international and domestic) Maintains regulatory files including submissions, technical files, etc Assists in regulatory body (including Notified Body and FDA) internal & customer audits, product recalls, Vigilance, MDR reportability, as necessary Interfaces with customer service and engineering on customer complaints and complaint investigations Ensures customer complaints, MDRs and global vigilance reporting are addressed in a timely manner according to the risk level per company and regulatory standards Assists customer service and quality team in improving the customer complaint process and procedures Management of domestic and international Standards, directives, regulations, etc. for gap analysis according to the latest revision Assist in the internal & external audits Maintenance of the Supplier Approval List Independently handle problems that arise within area of responsibility Able to assist Freudenberg Medical departments in gathering data or special assignments with limited assistance Performs in-depth review of regulatory data/information and provide oversight of query resolution and database to Supervisor Able to change priorities when directed by Supervisor/Manager Interacts effectively with other employees within the department and the company, Required Qualifications Bachelor of Science Degree in related field e.g. Microbiology, Biology or related field Must have a minimum of 5+ years of experience in a regulated industry (e.g., medical devices, pharmaceuticals, etc.). Regulatory Affairs experience is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Ability to develop SOPs and guidance documents using good technical writing practices. Ability to communicate key ideas verbally and in writing clearly and concisely to include presentations to management and to cross-functional team members. Demonstrated knowledge in Quality System Regulations/Good Manufacturing Practices. Able to read and comprehend federal and international (English Language Version) regulatory standards and guidelines. Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab and Microsoft Project Assertive, takes initiative, self-starter, energetic, motivated and self-managed. Able to organize data and information into clear, concise, and legible report format. Positive, respectful, and professional attitude. Able to handle diverse activities simultaneously. Strong critical thinking and problem solving tools. Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization. Detail orientated, organizational skills and the ability to handle multiple projects. Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work, Its an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at ., To Apply: Candidates meeting these qualifications should complete the online application:, Freudenberg Medical is an Equal Employment Opportunity Employer.