Manager, Regulatory Compliance

Company: ORTHOFIX Inc
Location: Lewisville
Posted on: November 17, 2021

Job Description:

Why Orthofix? Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision "To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders." Manager, Regulatory Compliance How you'll make a difference? This position is responsible for developing, defining, educating, advocating, and managing a superior compliance culture throughout Orthofix. Likewise, this position must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. This position is responsible for ensuring Orthofix management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are being followed. What will your duties and responsibilities be? Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Management Responsibilities: * Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA's Quality System Regulation, the European Medical Device Directive, ISO13485, and other relevant domestic and/or international regulatory requirements. * Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, etc. * Monitors completion of Post-Market activities, including complaint handling, to verify satisfaction of regulatory requirements, and manages or supports Recalls and Field Removals. * Maintains awareness of regulatory landscape and takes appropriate steps to ensure continued QMS compliance. * Ensures the Quality Policy and Manual have been effectively established, communicated, and implemented to maintain compliance with domestic and/or international regulatory requirements. * Verifies CAPA's are implemented as required to maintain suitability of both products and the Quality System * May provide training and/or training presentation documentation pertaining to FDA inspections, e.g. FDA hot topics, interaction with FDA officials, new regulatory approaches to inspections, etc. * Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures. * Monitor risk management process, including post-production risk, to ensure all regulatory and compliance obligations are satisfied. What skills and experience will you need? * Bachelor's degree in engineering field or equivalent * 10 years' experience in medical device industry, with 6 years related quality systems, quality auditing, and/or regulatory compliance experience * Knowledge of domestic and international medical device quality system laws, regulations and standards, such as 21CFR Part 820, ISO 13485:2016, ISO 14971, and ISO 11135. * Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically. * Project planning and management capability a must * Computer knowledge: MS Word; MS Excel, MS Project, Visio, outlook, access, etc. * Logical cognitive skills and ability to apply scientific methods and/or systems thinking * Ability to identify variables affecting all aspects of quality * Ability to meet deadlines and/or objectives as directed * Must be able to interpret device law into workable, efficient and effective practices and procedures. * Lead auditor certification highly desired What skills and experience would be helpful? * Knowledge of internet investigation for new and updated standards * Experience with global audits such as with Brazil and Japan * Current with domestic regulatory thinking * Experience in the spine and/or orthopedic industry * Experience with medical device reporting and complaint management a strong plus Will you have supervisory responsibilities? * Yes What will the physical demands and work conditions be like? The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs. * Eyesight and hearing must be correctable to standard level. * Travel required 10%, therefore must be able to utilize airplane, taxi and car. Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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