Regulatory Affairs - Specialist 3

Sunrise Systems, Inc.; Irvine (CA); On-site; USD 69,510 - 126,382; Full time

Job summary

A leading regulatory consulting firm is urgently seeking a Regulatory Affairs Specialist to oversee and implement regulatory submissions in Irvine, California. The ideal candidate should have in-depth knowledge of healthcare regulations and demonstrate the ability to work independently while mentoring less experienced colleagues. The position offers a contract duration of 9 months with a salary range of $69,510 to $126,382.

Qualifications

• In-depth experience in regulatory affairs and ability to work independently.
• Demonstrated knowledge of preparing regulatory submissions.
• Experience interacting with regulatory bodies.

Responsibilities

• Plan and implement regulatory submissions for products.
• Ensure compliance with relevant regulatory requirements.
• Translate technical data into reviewer-friendly content.

Skills

Knowledge of healthcare-related regulations

Ability to work independently

Strong communication skills

Job description

Regulatory Affairs Specialist - Onsite (Urgent Need)

Location: Irvine, CA | Contract Duration: 9 months | Salary: $69,510.00 - $126,382.00

Overview

Locals Only - Onsite in Irvine, CA (Hybrid)

Responsibilities

• Planning, coordinating, and implementing regulatory submissions for products requiring government approval.
• Demonstrated working knowledge of healthcare-related regulations.
• In-depth knowledge of preparing a submission and understanding of industry and competitive products.
• Application of relevant regulations and statutes to further product submissions of basic to medium complexity.
• Contributing to the strategic direction of regulatory pathway development.
• Refining and conforming the preliminary data used in the submission process.
• Translating technical data and descriptions into reviewer-friendly content.
• Ensuring that the appropriate regulatory requirements for the submission are met.
• Interacting with regulatory bodies to help further product approvals or clearance.
• In-depth experience, knowledge, and skills in own job family.
• Applying knowledge and skills to a wide range of standard and non-standard situations.
• Working independently with minimal guidance and usually determining own work priorities.
• Acting as a resource for colleagues with less experience.

Qualifications

In-depth experience, knowledge, and skills in the regulatory affairs job family, including the ability to work independently and act as a mentor to less experienced colleagues.