Hiring a Document Control Specialist for a remote opportunity asap for a great scientific company in West Sacramento, CA!

Needs to have ISO 13485 experience!

Description:

Position Summary

This candidate will assist in the proper labeling of the products produced at the company's manufacturing facilities. The ideal candidate should have knowledge in regulations related to cGMP and device GMP as well as the regulations in other jurisdictions like Europe, Asia and Australia. This candidate will participate in audits as needed and support filings that the company will perform. The Regulatory Affairs Specialist/Manager will work closely with the operations team, directly report to the CEO and indirectly report to the COO.

Reporting Relationships

Direct Supervisor: CEO

Indirect Supervisor: COO

Key Responsibilities

• Confirm compliance for marketed products based on labeling claims with respect to all regions that the products will be sold

• Assist in audits as needed

• Prepare and submit filings for the different regulatory organizations

• Work with Operations to assemble quality and compliance dossiers for the various products

• Work with Operations to perform gap assessments for customers related to their products

• Prepare filings for different jurisdictions

Required Skills/Abilities

• Understanding of 21CFR600, 820 and ISO13485 regulations

• Experience in regulatory filings with FDA and other major regulatory agencies

• Good written and verbal communication skills

• Have had direct communication with regulatory agencies

Personal Attributes

• Displays understanding of and promotes company and customer objectives

• Readily adapts to changing job duties

• Works well in a team environment

• Detail oriented

• Responds quickly to assignments

Skills:

Iso 13485, Regulatory affairs, Medical device, Fda, Labelling, Compliance, 21CFR600, 21CFR820, type one medical device, 510K

Top Skills Details:

510K projects, regulatory affairs, ISO13485, FDA, 21CFR820, regulatory compliance, GMP, medical device

Additional Skills & Qualifications:

Required Skills/Abilities

• Understanding of 21CFR600, 820 and ISO13485 regulations

• Experience in regulatory filings with FDA and other major regulatory agencies

• Good written and verbal communication skills

• Have had direct communication with regulatory agencies

Experience Level:

Intermediate Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.