RA Specialist I - Temporary

About the role

Provide regulatory support for IVD products with multiple product groups, focusing on clinical diagnostics. Assemble low to medium complexity regulatory submissions to support worldwide product registration change requests under the IVDR framework. Daily responsibilities include interfacing with desktop publishers, technical writers, and regulatory specialists.

Responsibilities

• Assemble regulatory submissions for IVD products
• Support product registration change requests globally
• Interface with desktop publisher, technical writers, and regulatory specialists
• Collaborate with R&D, QA, Planning, and Manufacturing teams

Requirements

• Strong prioritization skills
• Flexibility to handle multiple projects simultaneously
• Effective communication with employees across multiple departments
• Highly organized and detail-oriented
• Technical aptitude for understanding IVD product features
• Understanding of databases and electronic systems

Qualifications

• Education: BS in Biology or other scientific field
• Work Experience: 6 months - 2 years experience in IVD regulatory affairs
• Proficient use of MS Office applications (Excel, Word, PowerPoint, Teams)
• Laboratory research experience in an IVD medical device regulated environment is strongly preferred
• Understanding of scientific reports, risk management, and Quality Systems

Skills

• Strong prioritization and project management skills
• Excellent communication and interpersonal skills
• Attention to detail and organizational abilities
• Technical aptitude for IVD product features
• Experience with databases and electronic systems

Benefits

Not specified

Pay

The estimated hourly range for this position is $35.00 to $40.00 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Schedule

Not specified

Who We Are

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Fraud Alert

Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.