Job Description

Job Description

Job Description

Description:

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, China and 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; plus Managing and preparing submissions and amendments 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:

• Assist in the preparation of regulatory submissions and filings, such as: applications, amendments, supplements, annual reports, authority inquiry 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 products, processes, and quality system elements.
• Identify and record potential problems relating to products, processes, and quality system.
• Initiate, recommend or provide solutions through designated channels.
• Provide regular updates to the Director of Regulatory Affairs and Company management on International Regulatory Affairs status, plans, budgets, timetables, and bottlenecks.
• Other duties as assigned.

We are committed to growing a diverse team across the U.S. However, due to state-specific employment law and compliance considerations, we are currently unable to hire employees residing in California, Colorado, Connecticut, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Rhode Island, Vermont, and Washington .

We hope to expand our ability to hire in more states in the future and encourage you to check back as opportunities evolve.

Requirements:

• 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 international 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.

Qualifications:

• 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, EU MDR, MDSAP & 21 CFR 820.
• Excellent communicator who radiates compassion, integrity, and loyalty to SynCardia and its customers, partners, shareholders, and employees.

Work Environment:

The role is primarily office-based, with hybrid or remote options available depending on business needs. It requires flexibility to provide occasional after-hours support to address urgent shipment issues. The working environment involves moderate noise levels and may occasionally require lifting items weighing up to 25 pounds.

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