Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
We seek a highly motivated, detail-oriented Documentation Specialist to join our team. The successful candidate will be crucial in updating regulatory compliance information in logs, databases, and catalogs and maintaining compliance with the review and approval of medical device batch records.
The opportunity:
-
Update and maintain regulatory compliance logs, databases, and catalogs.
-
Coordinate the review and revision of procedures, and forms to ensure alignment with current GxP standards.
-
Prepare process and status reports to provide insights into compliance activities.
-
Assign and monitor document numbers, ensuring all documentation is accurate and complete.
-
Review documents for accuracy, consistency, and completeness before submission.
-
Maintain computerized documentation systems to support manufacturing processes.
Who you are:
Minimum qualifications:
-
High school diploma (or equivalent experience)
Preferred Qualifications:
-
3+ years of experience in regulatory compliance or documentation management.
-
Strong understanding of regulatory compliance requirements in the medical device industry.
-
Excellent attention to detail and organizational skills.
-
Proficient in using documentation management software and tools.
-
Strong communication and collaboration skills.
-
Ability to work independently and manage multiple tasks effectively.
Relocation benefits are not available for this job posting.
Pay transparency
The expected salary range for this position based on the primary location of Indianapolis is 46,700.00 - 86,700.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
-
Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
-
Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
-
Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
Similar Jobs
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
