Regulatory Affairs Specialist

Ultimate Staffing; Union City (CA); On-site; USD 100,000 - 120,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory Affairs Specialist to join their dynamic team in California. This pivotal role involves ensuring compliance with domestic and international regulations within the medical device sector. The ideal candidate will leverage their extensive experience in regulatory submissions to manage documentation and maintain regulatory databases. With a focus on collaboration and communication, you will support the Regulatory Affairs department while contributing to the organization's overall mission. If you are passionate about regulatory compliance and ready to make an impact, this opportunity is perfect for you.

Qualifications

• 8-10 years of experience as a Regulatory Affairs Specialist.
• Strong background in regulatory submissions and medical device industry.

Responsibilities

• Ensure compliance with internal Quality System policies and external regulations.
• Compile, prepare, review, and submit regulatory documents.

Skills

Regulatory submissions

Communication skills

Attention to detail

Interpersonal skills

Knowledge of 21 CFR

Experience with international product registration

Education

Bachelor's Degree in a technical discipline

Tools

MS Word

MS Excel

MS PowerPoint

Job description

This range is provided by Ultimate Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100,000.00/yr - $120,000.00/yr

Position Overview

Ultimate Staffing Services is actively seeking a dedicated Regulatory Affairs Specialist to join their client's team in Union, California. This position will play a crucial role in supporting the Regulatory Affairs department and the broader organization by ensuring compliance with both domestic and international regulations. The ideal candidate will have a strong background in regulatory submissions and experience in the medical device industry.

Responsibilities

• Manage and support the Corporate Vision, Mission & Values Statements and company goals.
• Ensure compliance with internal Quality System policies, procedures, and applicable external regulations, including 21 CFR Part 820 Quality System Regulations.
• Compile, prepare, review, and submit regulatory documents, including Device Master files, technical files, and annual reports, under the direction of the Manager, Regulatory Affairs.
• Gather and assemble necessary information for submissions in accordance with regulations and guidelines.
• Maintain a regulatory database and ensure all information is current and accurate.
• Review and present regulatory policies, methods, SOPs, protocols, and reports to ensure regulatory compliance.
• Assist in the implementation and delivery of regulatory documentation.
• Participate in training courses to stay informed on current trends, laws, regulations, and guidelines in medical device development.
• Develop rapport within the company regarding regulatory matters and maintain timelines for submissions.
• Maintain Device Manufacturing licenses as required by regulatory agencies.
• Assist in coordinating responses to requests or questions from government authorities.

Qualifications

• Bachelor's Degree (or equivalent) in a technical discipline such as engineering, biology, or chemistry.
• 8-10 years of experience as a Regulatory Affairs Specialist, with at least 2 years in the medical device industry.
• Excellent oral and written communication, interpretive, and interpersonal skills.
• Strong attention to detail and the ability to manage multiple tasks.
• Experience with international product registration and knowledge of regulations for cybersecurity, wireless, and sterile products.
• Knowledge of 21 CFR and FDA guidelines (GMPs).
• Proficiency in MS Word, Excel, and PowerPoint.

Work Environment

The work environment involves an office setting with standard equipment such as computers and telephones. The noise level is typically low to moderate. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.

Work Hours

Monday - Friday, 8:00 AM - 5:00 PM

Salary and Benefits

Salary range: $100,000 - $120,000 per year.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.

Seniority level

Entry level

Employment type

Full-time

Job function

Manufacturing

Industries

Medical Equipment Manufacturing