- Assist in the preparation of regulatory submissions and filings, such as applications, amendments, supplements, annual reports, deficiency letter responses, Form 483
- responses, warning letter responses, adverse experience reports, recall communications, license renewals, registrations, reports, correspondence, and telecommunications.
- Gather, assemble, and prepare appropriate documents for submission supporting the EU and other international markets.
- Independently research regulatory issues and/or information as directed.
- Independently track and follow-up on Regulatory commitments to assure commitments are completed and maintained.
- Prepare documents, as directed, for internal use or submission to regulatory authorities.
- Support regulatory filing processes in collaboration with a multi-disciplinary professional support staff.
- Independently monitor and improve tracking/control systems for regulatory documents.
- Participate in Design Control meetings with Product Development to provide regulatory input.
- Initiate action to prevent the occurrence of nonconformities relating to the product, process, and Quality System.
- Identify and record potential problems relating to the product, processes, and Quality System.
- Initiate, recommend or provide solutions through designated channels.
- Other duties as assigned.
- Provide regular updates to the Director of Regulatory Affairs and Company management on clinical International Regulatory Affairs statuses, plans, budgets, timetables, and bottlenecks.
- Minimum of 5 years of International Regulatory Affairs experience gained in a similar position with at least 3 years in the cardiovascular device arena
- University degree from a top-tier academic institution in a relevant field
- Extensive knowledge of relevant government regulations, standards and guidelines
- Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player.
- Proven track record of working in a dynamic, international environment
- Excellent written and spoken English.
- Proven experience of successfully directing the efforts of diverse teams located across multiple locations/time zones is required
- Effective team builder and problem solver, exhibiting a collaborative management style and the ability to bring out the best in people through example.
- Strong regulatory and business mind; he/she should be able to visualize future strategy while also outlining and driving tactics to complete the milestones to successfully execute that strategy.
- Comfortable leading the execution of all aspects of International Regulatory Affairs including prioritization of projects
- Advanced experience and knowledge of ISO 13485, MDR, MDSAP & 21 CFR 820
- Excellent communicator who radiates compassion, integrity, and loyalty to SynCardia and its customers, partners, shareholders, and employee.
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International Regulatory Affairs Manager - Tucson, United States - HRPivot
Description
Company description:SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and sell the world's first and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart as bridge to transplant for patients suffering from biventricular heart failure The SynCardia Total Artificial HeartTM is available in two sizes to accommodate patients' diverse physiologies. The Freedom Portable DriverTM allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant. The SynCardia Total Artificial HeartTM has been successfully used in over 2,000 patients and is the most widely used and extensively studied total artificial heart in the world. For additional information and label information, visit us at
Position description:
SynCardia is looking for an energetic International Regulatory Affairs Manager. The successful candidate will be responsible for managing SynCardia's international product registrations in Canada, Europe, and in the rest of the world. Specific tasks will include planning, preparing, managing, monitoring, and budgeting the Company's international regulatory affairs projects: coordinating and working with regulatory consultants; and managing and preparing submissions to authorities in SynCardia's international markets. To this end, the International Regulatory Affairs Manager will be working together with Regulatory Affairs, Quality, R&D, and Clinical Affairs professionals at the Company's Tucson site. Moderate travel is required..
Principal responsibilities:
