Job Description

Position Overview

Ultimate Staffing Services is actively seeking a dedicated Regulatory Affairs Specialist to join their client's team in Union City, 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. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Job Tags

Work at office, Local area, Monday to Friday,

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