Regulatory Affairs Specialist (Technical Writing)

Biocomposites; Keele; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Company events

Company pension

Employee discount

Free or subsidised travel

Free parking On-site

Job summary

Biocomposites, based in Keele, UK, seeks a Regulatory Affairs Specialist (Technical Writing) to lead the creation and revision of clinical evaluation reports (CER) and assist with regulatory submissions such as FDA Q-submissions. The role requires coordinating with R&D, clinical, and regulatory teams, performing literature reviews, and ensuring compliance with EU MDR 2017/745 and MDCG guidance.

The position reports to the Senior Regulatory Affairs Specialist (Technical Writing) and is based at

Qualifications

• Bachelor’s Degree in life science or equivalent.
• Minimum 5+ years of Technical Writing experience in pharma/medical device.
• Experience writing CERs and PSURs per EU MDR 2017/745 and MDCG guidance.
• Experience with systematic literature searches and reviews.
• Experience with regulatory submissions including EU MDR and US FDA Q-submissions.
• Compilation of Technical Files/Documentation to MDR 2017/745 or MDD 93/42/EEC.
• Knowledge of ISO13485/ISO14971/ISO10993 and MDSAP.
• Proficient in MS Office (Word, Excel); familiarity with Endnote/Reference Manager.

Responsibilities

• Prepare and revise clinical evaluation reports and other regulatory documents.
• Collaborate with R&D, clinical, technical and regulatory teams for submissions.
• Conduct literature searches and critically appraise clinical data.
• Analyze clinical data from investigations and post-market activities.
• Support global submission dossiers and regulatory communications.
• Ensure documentation meets EU MDR, FDA guidance and ISO standards.
• Mentor junior regulatory staff and provide training as needed.
• Contribute to quality control checks of documentation prior to approval.
• Respond to regulatory authorities and Notified Bodies under supervision.

Skills

Technical writing

Clinical evaluation reports

Regulatory submissions

MS Office

Literature reviews

Data analysis

Attention to detail

Independent work

Education

Bachelor’s degree in life science

Masters or PhD level (desirable)

Tools

Endnote

Reference Manager

Adobe Acrobat Pro

Job description

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 Technical Writingwithin 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 andUS 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