What are the responsibilities and job description for the Regulatory Affairs Specialist position at Ultimate Staffing?
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.
Salary : $100,000 - $120,000
