Regulatory specialist Work, Jobs in Stoke On Trent, Eng (with Salaries)

Regulatory Affairs Specialist (Technical Writing)
Biocomposites —Keele
- Full-time
- Microsoft Word
- Doctoral degree
- Data analysis skills
- Free parking
- Employee discount
Quick apply
3d
Senior Regulatory Specialist
Ecolab Inc. —Northwich
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
QA Systems Specialist
Bespak —Holmes Chapel
- £46,000 a year
- Temporary
- Free parking
Quick apply
Junior People Partner
Hometree Group —Stoke-on-Trent
- £35,000 - £40,000 a year
- Full-time
- Hybrid work
- Management
- IT
- In-person
- Employee discount
Quick apply
Quality Assurance Officer
Gray Healthcare Ltd —Macclesfield
- £30,000 - £35,000 a year
- Full-time
- Travel
- In-person
- Care plans
- Free parking
Quick apply
Customer Outcomes & Complaints Lead
Leek Building Society —Leek
- Up to £40,000 a year
- Full-time
- Hybrid work
- Microsoft Office
- Analysis skills
- Continuous improvement
- Annual leave
- Sick pay
Quick apply
Residential Children's Worker - Full Time - 2:4 Shift Pattern including sleep-ins
Crystal Care Solutions Ltd —Stoke-on-Trent
- £28,806.96 - £37,795.89 a year
- Weekend availability
- Childcare
- Microsoft Office
- Experience working with children
- Annual leave
- Employee discount
Quick apply
Health, Safety and Medical Compliance Officer
Petty Pool Vocational College —Northwich
- £31,508.31 - £35,462.88 a year
- Full-time
- Organisational skills
- Care plans
- Communication skills
- Free parking
- Annual leave
Quick apply
2d
Registered Manager - Stoke on Trent
Crystal Care Solutions Ltd —Stoke-on-Trent
- £55,500 - £69,500 a year
- Weekend availability
- Microsoft Word
- Childcare
- Microsoft Excel
- Annual leave
- Employee assistance programme
Quick apply
4d
QA Manager - Projects and NPI Support
Bespak —Holmes Chapel
- £55,000 a year
- Leadership
- Free parking
Quick apply
Qualification & Validation Specialist
Bespak —Holmes Chapel
- £55,000 a year
- Free parking
- Life insurance
Quick apply
Senior Master Data Specialist
JCB —Rocester
- Full-time
- Engineering
- Gym membership
Quick apply
10d
Customer Support Specialist- Fixed Term (12 months)
Health Shield Friendly Society Ltd —Crewe
- £26,699.67 a year
- Full-time
- Customer service
- English
- Microsoft Office
- Free parking
Quick apply
Support Worker - Full Time - 2:4 Shift Pattern including sleeps
Crystal Care Solutions Ltd —Nantwich
- £27,300.00 - £35,725.96 a year
- Weekend availability
- Microsoft Word
- Childcare
- Microsoft Excel
- Annual leave
- Employee discount
Quick apply
Deputy Manager
SGS Care Ltd —Stoke-on-Trent
- £20.86 an hour
- Overtime
- Microsoft Word
- Childcare
- Microsoft Excel
- Annual leave
- Employee assistance programme
Quick apply
Deputy Children's Manager
Crystal Care Solutions Ltd —Stoke-on-Trent
- £38,849.56 - £39,425.02 a year
- Weekend availability
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Employee discount
Quick apply
Principal Geo-Environmental Consultant
SLR Consulting —Stoke-on-Trent
- Full-time
- Business development
- Project management
- Presentation skills
- Annual leave
- Employee assistance programme
4d
Payroll Specialist
Gray Healthcare Ltd —Macclesfield
- £38,000 - £40,000 a year
- Full-time
- Microsoft Excel
- Organisational skills
- Communication skills
- Free parking
Quick apply
Team Leader - Residential Children's Home
Crystal Care Solutions Ltd —Stoke-on-Trent
- £38,849.56 a year
- Weekend availability
- Microsoft Word
- Childcare
- Microsoft Excel
- Annual leave
- Employee discount
Quick apply
9d
Graduate Compliance Risk Officer
The Access Bank UK —Northwich
- £25,000 a year
- Full-time
- Hybrid work
- Analysis skills
- Communication skills
- Banking
- Employee assistance programme
Quick apply

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regulatory specialist jobs near stoke on trent, eng

Regulatory Affairs Specialist (Technical Writing)

Biocomposites -
Keele

Quick apply

Job details

Full-time
3 days ago

Benefits

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

Qualifications

Microsoft Word
Doctoral degree
Data analysis skills
Microsoft Office
Diagnostic evaluation
Master's degree
Bachelor's degree
Organisational skills
Adobe Acrobat

Full 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 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

Quick apply

Refine Your Search

regulatory specialist jobs in stoke on trent, eng

Regulatory Affairs Specialist (Technical Writing)

Senior Regulatory Specialist

QA Systems Specialist

Junior People Partner

Quality Assurance Officer

Customer Outcomes & Complaints Lead

Residential Children's Worker - Full Time - 2:4 Shift Pattern including sleep-ins

Health, Safety and Medical Compliance Officer

Registered Manager - Stoke on Trent

QA Manager - Projects and NPI Support

Qualification & Validation Specialist

Senior Master Data Specialist

Customer Support Specialist- Fixed Term (12 months)

Support Worker - Full Time - 2:4 Shift Pattern including sleeps

Deputy Manager

Deputy Children's Manager

Principal Geo-Environmental Consultant

Payroll Specialist

Team Leader - Residential Children's Home

Graduate Compliance Risk Officer

I want to receive the latest job alerts for regulatory specialist in stoke on trent, eng

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