Professional - Spec Regulatory Affairs

Role: Professional Regulatory Affairs Specialist

Location: Irvine CA 92614

Duration: 12 Months of Contract to begin with possible extension

Job Description:

Purpose:

Completes and maintains regulatory approvals and clearances of medical device products.

Key Responsibilities:

• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Present alternatives for meeting regulatory requirements and resolve conflicts between those requirements and development issues and/or reporting to management
• Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions.
• May interact with regulatory agencies as part of submission review and onsite audit support (e.g. US FDA EU notified bodies Japan PMDA Australia TGA Japan PMDA other global regulatory agencies submissions dossiers and technical files)
• Provide guidance on regulatory requirements necessary for contingency planning
• Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process
• Review labeling content product and process changes and product documentation to assure regulatory requirements compliance consistency and accuracy.
• Prepare documents for submissions to global regulatory bodies.

Experience:

Experience with EU MDR preferred.

Coursework seminars and/or other formal government and/or trade association training required.

Proven expertise in Microsoft Office Adobe.

Experience in product lifecycle management systems (Agile Teamcenter etc.)

Preferred

Good written and verbal communication skills and interpersonal relationship skills

Good problemsolving organizational analytical and critical thinking skills

Additional Skills:

• Must be able to work in a team environment including interdepartmental teams and representing the organization on specific projects.
• Ability to build productive internal/external working relationships.
• Develops solutions to a variety of problems of moderate scope and complexity.
• Contributes to process improvements.
• Exercise judgment within defined procedures and practices to determine appropriate regulatory action/requirements for new products or product changes and preparation of regulatory documents.

Education and Experience

• Bachelors Degree or equivalent in scientific discipline (e.g. Biology Microbiology Chemistry)
• 24 years of experience required.

• Ignite PLM (Team center)
• Labeling software

Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website