Technical Writer III

Bio-Rad Laboratories; Irvine, California, Town of Brookhaven (CA, MO, NY); On-site; USD 94,000 - 130,000; Full time

Job summary

Join a forward-thinking company as a Technical Writer III, where you'll play a crucial role in ensuring that medical device documentation meets regulatory standards and customer expectations. In this position, you'll translate complex technical information into clear, structured documentation while collaborating with cross-functional teams. Your expertise in regulatory requirements and quality management systems will be essential in supporting product launches and ensuring compliance. This innovative firm offers a competitive salary and comprehensive benefits, making it an exciting opportunity for those passionate about making a difference in healthcare.

Benefits

Competitive medical plans

401k plus profit sharing

Paid parental leave

Employee stock purchase program

Education benefits

Wellness challenges and support

Paid time off

Pet insurance

Qualifications

• 5+ years in Medical Device or IVD experience required.
• Familiarity with ISO 13485 and ISO 14971 standards.

Responsibilities

• Provide technical writing for medical device documentation.
• Collaborate with various teams to ensure regulatory compliance.

Skills

Technical Writing

Regulatory Knowledge

Project Management

Communication Skills

Attention to Detail

Education

Bachelor's degree in Life Science

Bachelor's degree in Engineering

Tools

Microsoft Office

Adobe Acrobat Pro

Adobe InDesign

Job description

As the Technical Writer III, you will provide technical writing for medical device and in vitro diagnostic products to ensure regulatory compliance and customer expectations are met, including but not limited to technical documentations, regulatory reports, Instruction for Use (IFU), and product notifications.Work with local and regional Regulatory Affairs to obtain an in-depth understanding of the intended use and use environment of Bio-Rad products. Translate technical and scientific information from subject matter experts (SMEs) into clear and structured documentation meeting regulatory requirements and customer expectations. Facilitate drafting and reviewing of Quality Management System (QMS) Standard Operating Procedures (SOP), technical documentation, labeling materials for compliance with applicable regulations and standards. Assess impact from product changes and manage routing labeling in the document control system.

How You'll Make An Impact:

• Manage translation requests and localization to support the sales of product portfolios as well as worldwide market expansion. Coordinate translations requests with vendors for multi-language labeling updates.


• Collaborate with Marketing, R&D, Clinical Affairs, Quality, Desktop Publishing, Planning, and Manufacturing teams.


• Support projects as needed.


• Strong prioritization skills and ability to handle a large volume of projects simultaneously while meeting deadlines.


• Ability to communicate effectively with all levels of employees across multiple departments.


• Highly organized and detail-oriented. Good time management.


• Technical aptitude for learning IVD products.


• Knowlegeble with product design control process.

What You Bring:

• Bachelor's degree (BS/BA) in Life Science, Engineering or related field.


• Minimum of 5 years in Medical Device or IVD. Familiar with Quality Management Systems requirements, such as ISO 13485 and ISO 14971.


• Regulatory Knowledge: Familiarity with FDA and CE marking requirements for IVD products. Prior experience in regulatory is preferred.


• Technical Writing: Experience in writing IFUs, labeling materials, customer notifications, recall notification, or other quality system documentations.


• Proficient in Microsoft Office applications (e.g., Excel, Word, PowerPoint, Visio), Adobe Acrobat Pro, and Adobe InDesign.


• Customer-centric mindset with the ability to understand customer and regulatory requirements, anticipate challenges, and develop clear instructions and communications.

Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.

Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!

Compensation: The estimated base salary range for this position is $94,100 - $129,400 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. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

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. #LI-AK1 #LI-Hybrd

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.