Senior Regulatory Specialist Jobility Talent Solutions Inc. Alameda, CA Job Details Contract $82 - $84 an hour 1 hour ago Benefits Referral program Qualifications Drug regulation Attention to detail Biomedical regulatory compliance Risk & issue management Continuous process improvement (CPI) Full Job Description Job Overview We are seeking a highly skilled and detail-oriented Senior Regulatory Specialist to join our dynamic team. In this pivotal role, you will oversee the development, submission, and management of regulatory documentation for pharmaceutical products, ensuring compliance with international health regulations and standards. Your expertise will support our commitment to delivering safe and effective healthcare solutions globally. The ideal candidate will possess extensive knowledge of FDA regulations, EMA guidelines, ICH standards, and biomedical regulatory compliance practices. This position offers an exciting opportunity to lead complex regulatory projects, collaborate across departments, and contribute to the advancement of innovative therapies.

Years Experience:

Must have 7 years of experiences in Medical Device Regulatory Affairs Considered as highly experienced with regulatory change assessments. Working knowledge in US Medical Device Submissions Participates in some of the following: continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence. Ensures timely approval of new medical devices and continued approval of marketed products. Serves as regulatory representative to cross-functional teams. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling

Pay:

$82.00 - $84.00 per hour

Benefits:

Referral program

Work Location:

In person