SynCardia Systems, LLC · 2 months ago
International Regulatory Affairs Manager
United States
Full-time
Remote
Senior Level
5+ years expSynCardia Systems, LLC is looking for an energetic International Regulatory Affairs Manager responsible for managing international product registrations across various markets. The role involves planning, preparing, and managing regulatory affairs projects while collaborating with multiple departments to ensure compliance with international regulations.
Health CareManufacturingMedicalWellness
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
Qualification
Required
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
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
Company
SynCardia Systems, LLC
SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ.
51-200 employees
H1B Sponsorship
SynCardia Systems, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$39.42MKey Investors
SWK Holdings
2021-09-28Acquired
2014-09-15Series Unknown· $6.42M
2013-12-23Series Unknown· $14M
Leadership Team
Don Webber
Chief Executive Officer
Patrick NJ Schnegelsberg
Chief Executive Officer
Recent News
2025-12-30
Company data provided by crunchbase