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Terumo Aortic · 1 day ago

Regulatory Affairs Associate II

Fort Lauderdale, FL

Full-time

Onsite

Mid Level

3+ years exp

Terumo Aortic is dedicated to transforming the treatment of aortic disease worldwide. They are seeking a Regulatory Affairs Associate II to support regulatory compliance and product approvals, ensuring alignment with domestic and international standards.

Health CareMedicalPersonal HealthTherapeutics

Responsibilities

Assist in the preparation of US, EU, and rest of world regulatory submissions as required

Review proposed labelling, packaging, advertising, and promotional materials after evaluating conformance to regulations

Review, edit and provide regulatory approval for project documentation

Review and analyse technical protocols, data, and reports generated by other departments

Partner with cross functional teams by providing preliminary regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities

Evaluate how design and manufacturing changes affect product registrations

Evaluate compliance to recognized and harmonized standards

Assist in SOP development, review, and initiation

Stay abreast of regulatory procedures and changes in regulatory climate

Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries

Provide Regulatory Affairs support during internal and external audits

Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA

Prepare and submit medical device reports or vigilance reports

Perform various other duties as assigned

Qualification

Medical device regulatory affairsUSEuropean regulatory processesRegulatory submissions preparationDesign Control processesRegulatory Standards (ISO 13485)Computer skillsInterpersonal skillsWritten communicationVerbal communicationAttention to detailOrganizational skills

Required

Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team

Excellent written, verbal communication and presentation skills are required

Excellent attention to detail and ability to coordinate multiple activities simultaneously

Excellent computer skills including expertise in Microsoft Office Products

Excellent organizational skills to maintain communications with teams and regulatory agencies

Bachelor's degree in science or engineering (or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs

Minimum 5 years direct experience in medical device regulatory affairs if no degree

Knowledge of US and European regulatory processes, including Class III is strongly preferred

Knowledge of Design Control processes and controls (21 CFR 820)

Knowledge of Regulatory Standards needed in the medical device environment (ISO 13485, current revision)

Awareness of Medical Device Directive and Medical Device Regulation

Preferred

Preferred experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required