Regulatory Affairs Specialist

Job Title

Job Responsibilities:

Determine international regulatory submission and approval requirements

Compile, prepare, review regulatory submission with in-country representatives and ensure on-time submission to relevant authorities

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and collaborate with management and cross-functional team to develop solutions

Provide regulatory input for responsible countries/region for product lifecycle planning

Monitor applications under regulatory review, and communicate application progress to internal stakeholders

Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

Identify emerging issues for responsible countries/region

Assess the acceptability of quality, preclinical and clinical documentation for submission filing

Provide registration impact assessment in responsible countries/region for design changes throughout the product lifecycle

Ownership of processes involved with maintaining annual licenses, registrations, listings in responsible countries/region

Review and approve advertising and promotional items to ensure regulatory compliance with intended markets

Ensure external communications for regulatory purposes meet regulations

Requirements:

Bachelor's degree (or Associate degree with 5+ years of relevant work experience)

2+ years of related regulatory submission experience from a medical device, in vitro diagnostic device, and/or pharmaceutical industry

Familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards

Proficient with MS Office suite (Word, Excel, Outlook, Powerpoint)

Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.