Coord 3, Regulatory Affairs

Immediate need for a talented Coord 3, Regulatory Affairs . This is a 12 months contract opportunity with long-term potential and is located in Irvine, CA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 26-03111

Pay Range: $50 - $54/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements.
• Participate in assessing and collating regulatory impact and developing regulatory strategy.
• Collaborate and approve change requests/change notifications.
• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content.
• Other incidental duties assigned by Leadership.

Key Requirements and Technology Experience: 

• Key skills: - Regulatory Affairs, Medical Device.
• Coursework, seminars, and/or other formal government and/or trade association training required
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience required

Our client is a leading Medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy