Regulatory Affairs Specialist I

4 months ago

Basingstoke, United Kingdom Thermo Fisher Scientific Full time

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Working as part of our Microbiology Division (MBD), within the Specialty Diagnostics Group, you’ll play an active part in helping us to achieve our mission to enable our customers to make the world healthier, cleaner and safer. The Microbiology Division discovers microbiological solutions for the diagnosis of infectious disease and detection of bacterial contamination. We serve public health, clinical laboratories, food companies, environmental screening and pharmaceutical laboratories with a portfolio of products that include culture media, antimicrobial susceptibility testing solutions and market-leading molecular solutions for food safety testing.

**Position Summary**:
A regulatory position within Thermo Fisher Scientific, Microbiology Division (MBD), working within the Regulatory Affairs (RA) Technical Writing Team as a Technical Writer to support MBD’s portfolio of clinical microbiology products.

As a Technical Writer, you’ll be responsible for compiling technical documentation to meet in vitro Diagnostic Regulation (IVDR) requirements. You’ll work in accordance with standard operating procedures (SOPs) and mentorship from the Technical Writing Team Manager and Technical Writing Specialists, to ensure work is carried out within schedule.

**Responsibilities**:
Working closely with the RA Technical Writing Team, you will be jointly accountable for the following:

- Compiling product-specific technical files
- Compiling Safety and Performance documentation.
- Researching/ reviewing relevant microbiology literature.
- Working on cross functional projects involving Technical, RA, QA and commercial departments.
- Building an understanding of the clinical microbiology portfolio.
- Planning projects in agreement with internal customers to agreed specifications.
- Completing work within agreed schedules.
- Communicating status updates to internal customers.

**Experience, skills & abilities required**:
We’re looking for someone who:

- Has a Microbiology (or another biological science related) degree or experience in microbiology laboratory setting
- Has knowledge of in vitro microbiological diagnostic devices
- Shows proficiency with Microsoft Office software including Word and Excel
- Demonstrates good organisational and communication skills
- Has high energy, with perseverance in a high pace environment
- Consistently demonstrates our 4i Values of Integrity, Intensity, Innovation & Involvement
- Puts the Customer First
- Thinks and acts with the customer always in mind and is dedicated to meeting or exceeding customer expectations
- Can explain who their customers are, and how their daily work impacts the customer
- Owns Their Results
- Takes personal accountability for their daily presence, performance, and productivity and always exercises good judgement
- Is highly reliable and consistently meets or exceeds job requirements
- Takes personal accountability for adherence to safety, compliance, quality, and security
- Finds a Better Way Every Day
- Adopt continuous improvement, asks questions and seeks opportunities to learn from others and from new experiences
- Takes the initiative to share ideas on how to make jobs easier and strengthen our performance

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