Regulatory Affairs Consultant

eTeam; Diamond Bar (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

eTeam is seeking a Regulatory Affairs professional in Diamond Bar, California. The role involves developing regulatory submissions, authoring documents for international registration, and ensuring compliance with regulations.

The ideal candidate will hold a BS degree in a relevant field and have 4-6 years of Regulatory experience. Excellent communication and project management skills are essential for this position.

Qualifications

• Minimum 4-6 years experience in Regulatory experience or 2-4 years with an advanced degree.
• Must have a solid understanding of regulatory requirements and process.

Responsibilities

• Develop regulatory strategies to ensure timely global commercialization.
• Author regulatory submissions for Class II and III medical devices.
• Directly communicate with FDA and other Regulatory agencies.

Skills

MS Office applications

Excellent communication skills

Project management skills

Problem solving skills

Presentation skills

RAC Certification

Education

BS degree in Engineering, Physical or Biological science

Advanced degree (preferred)

Job description

eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50

Job Description

Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
• Author regulatory submissions and assessments for Class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
• Author technical files and design dossiers for products to be distributed in the EU.
• Prepare international documentation to support product registration internationally.
• Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.
• Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal BWI policies and procedures.
• Participate on new product development teams.
• Review and approve new product development and product modification documentation.
• Write, review and revise company SOPs as required.
• Communicate business related issues or opportunities to next management level.
• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

Qualifications

BS degree in Engineering, Physical or Biological science + a minimum of 4 - 6 years experience in Regulatory experience or advanced degree + 2 - 4 years experience in Regulatory Affairs.

Required Knowledge, Skills, Abilities and Certifications/Licenses

• Must be familiar with MS Office applications
• Excellent communication skills (verbal and written)
• Project management skills
• Problem solving skills
• Presentation skills
• RAC Certification preferred