Regulatory Affairs Specialist (Technical Writing)

Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

Job Summary

The Regulatory Affairs Specialist (Technical Writing) is primarily responsible for leading the creation and revision of clinical evaluation reports (CER) to support regulatory submissions. They also provide support with the generation of other technical documentation (e.g. FDA Q-submissions, PSURs).

Reports to

Senior Regulatory Affairs Specialist (Technical Writing)

Location & Working pattern

Keele Science Park office. Mon-Fri, 8am-4pm or 9am-5pm

Duties & Responsibilities

• Primarily responsible for completing assigned clinical evaluation reports (CER) and other technical writing projects in a timely manner to meet business needs
• Collaborate (write, review, and edit) with R&D, clinical, technical and regulatory teams on the creation of clinical evaluation reports, pre-submissions and other documentation intended for regulatory submissions
• Conduct systematic literature searches for product-related data, including favourable and unfavourable data
• Critically appraise and analyse clinical data from various sources (e.g. clinical investigations, post-market activities and vigilance systems)
• Contribute to benefit-risk profile analysis for devices and show conformance to general safety and performance requirements
• Conduct thorough quality control (QC) checks of documentation to ensure accuracy and consistency prior to approval
• Contribute to discussions focused on gaps identified in available clinical data and support with any proposed strategies to address them
• Ensure all technical writing is prepared and compliant with applicable requirements (e.g. EU MDR 2017/745, FDA Q-submission guidance, ISO standards, MDCG guidance)
• Collaborate cross-functionally to ensure the accurate drafting and presentation of technical content within clinical evaluations and technical documentation
• Provide technical writing support for global submission dossiers
• Ensure conformance with applicable requirements in product development, support of claims, content labelling, and promotional materials
• Provide Regulatory Affairs support during internal and external audits
• Handle routine correspondence and enquiries with regulatory authorities and Notified Bodies as required, under the direct supervision of senior staff
• Conduct gap assessments; report, assess and communicate applicable changes in requirements
• Draft, update and maintain procedures relating to clinical evaluation and technical/regulatory writing
• Mentorship of junior regulatory staff members, as required
• Provide guidance, support and training to internal team members on clinical, technical and/or regulatory writing and applicable requirements
• Support global submissions with clinical, technical and/or regulatory writing requests
• Acts as a delegate for technical writing activities falling under the remit of the Senior Regulatory Affairs Specialist (Technical Writing), as needed

REQUIREMENTS

• Bachelor’s Degree in a life science or equivalent
• Minimum 5 Years’ experience of medical writing within the pharma or medical device industry
• Experience of writing clinical evaluation reports and PSURs in line with the EU MDR 2017/745 and MDCG guidance documents
• Experience of conducting systematic literature searches and reviews
• Experience of writing regulatory submissions including dossiers for EU MDR submission and/or US FDA Q-submissions.
• Compilation of Technical Files/Documentation to MDD 93/42/EEC or MDR 2017/745
• Knowledge of MDSAP, ISO13485, ISO14971, ISO10993
• Highly proficient in the use of MS Office applications (Word, Excel)
• Experience with medical writing tools (e.g., Endnote, Reference Manager) and publication tools (e.g. Adobe Acrobat Pro)
• Excellent scientific writing and organisational skills.
• Ability to interpret and succinctly summarise complex written information and data at the appropriate level for the intended audience.
• Strong data analysis skills
• Analytical thinking and inquisitive mindset
• Experience of prioritising large amounts of changing, complex workload from multiple sources and make timely and effective decisions for the execution of project objectives
• Attention to detail
• Self-motivated with ability to work independently

DESIRABLE REQUIREMENTS

• Masters or PhD level

• Training or qualification in medical device development or medical/regulatory writing

• Experience of quality or regulatory affairs within pharmaceutical industry

• Experience with implantable orthopaedic devices

• Experience of EU Class III medical device regulation and US 510k regulation

• Previous exposure to global registrations

• Previous exposure to notified body/regulatory agency audits

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

• Company events
• Company pension
• Employee discount
• Free or subsidised travel
• Free parking On-site