Regulatory Affairs Manager - Class II

Location: Carlsbad, California, United States
Salary: bonus, benefits
Job Type: Permanent
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Regulatory Affairs Manager responsibilities:
* Create and manage domestic and global product submissions (e.g. EU Technical Files, International Dossiers, 510ks), including CFGs, Certificates of Free Trade, and legalization of regulatory documentation
* Manage internal processes to meet FDA, EU, Health Canada, Notified Body, and other regulatory authority requirements
* Complete regulatory assessments for new products or product modifications and develop regulatory strategies for their respective product launches domestically and internationally
* Support and provide regulatory guidance on pre-production and design releases of new product development for domestic and international distribution
* Maintain current state and federal registrations (wholesale distribution)
* Review and approve labeling and promotional materials
* Manage regulatory compliance activities such as HHEs, adverse event reporting, and recall execution and reporting
* Monitor and communicate changes to regulations, legislation, guidance documents, and policy to determine the impact on the organization
* Oversee government inspection activities, including inspectional observations, as well as corrective action plans
* Oversee and maintain ongoing relationships with regulatory authorities
* Responsibilities include the development, implementation, and management of the Company's compliance functions
* Responsible for ensuring general compliance with Federal and State regulations applicable to the manufacture and distribution of medical devices, including facility licensure and product registration
* Communications with regulatory bodies on significant matters, including formal responses to regulators on submissions, with supervision
* Communicates regulatory requirements to functional leaders, exercises judgment on when to escalate regulatory queries for managerial input

Background requirements:
* Bachelor's degree required
* 7-10+ years of related experience in an FDA-regulated industry
* Prior Management experience required.
* Working knowledge of FDA, Canada, EU regulations; Quality System Regulations; MDSAP, and ISO certifications
* Strong understanding of manufacturing and/or distribution and auditing processes

Sthree US is acting as an Employment Agency in relation to this vacancy.

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