Information management system specialist Work, Jobs in Southampton, Eng (with Salaries)

Principal Regulatory Affairs Specialist - EMEA (Cluster Partner)
CooperVision —Southampton
- Full-time
- Microsoft Word
- Microsoft Outlook
- Computer literacy
Training Specialist
Leidos —Whiteley
- £44,700 - £57,300 a year
- Full-time
- Hybrid work
- Organisational skills
- Training & development
- Communication skills
- Annual leave
- Work from home
5d
Chief Technology Officer (CTO)
Hampshire and Isle of Wight Healthcare NHS Foundation Trust —Southampton
- £94,356 - £108,814 a year
- Full-time
- Master's degree
- AI
- Leadership
2d
Assistant Operations Manager
Now Student Living —Southampton
- £32,000 - £35,000 a year
- Full-time
- Sales
- Business development
- In-person
- Health & wellbeing programme
- Life insurance
Quick apply
8d
Customer Support Specialist (Customer Support Management)
Boeing —Gosport
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Analysis skills
- Bachelor's degree
2h
Mission Operations Specialist - UK
Saronic Technologies —Portsmouth
- Full-time
- Military
- Engineering
- Data analysis skills
- Annual leave
Team Leader - Customer-Centric Ways of Working and Collaboration
Southampton City Council —Southampton
- £47,181 - £51,357 a year
- Full-time
- Continuous improvement
- Communication skills
- Employee assistance programme
- Employee discount
9d
Trade Compliance Specialist
Leonardo UK Ltd —Southampton
- £54,000 - £68,000 a year
- Full-time
- Hybrid work
- Computer literacy
- Microsoft Office
- Presentation skills
- Flexible schedule
- Referral programme
14d
ICT Technical Manager HIWFRS624695
Hampshire & Isle of Wight Fire and Rescue Authority —Eastleigh
- Hybrid work
- No degree
- Communication skills
- Free parking
Information Officer
IWT PHU Single Corporate Service —Portsmouth
- £32,073 - £39,043 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Computer literacy
Quick apply
7d
Locality Administrator
Hampshire and Isle of Wight Healthcare NHS Foundation Trust —Southampton
- £25,760 - £27,476 a year
- Full-time
- Microsoft Office
- Organisational skills
- IT
2d
Commercial Contract Specialist II
Parker Hannifin Corporation —Fareham
- Full-time
- Analysis skills
- Bachelor's degree
- Conflict management
- Free parking
- Employee assistance programme
Conformity Assessment Procedure Specialist (CAPS) - UKCA & Global Regulatory Affairs Specialist
TÜV SÜD —Fareham
- Full-time
- Engineering
- English
- Analysis skills
Logistics Supervisor (Fareham - Full Time - Logistics experience required)
Astor Defence Ltd —Fareham
- £33,000 - £36,000 a year
- Full-time
- English
- Administrative experience
- In-person
- Free parking
Quick apply
18h
Laboratory Programme Manager
CBRE —Southampton
- Full-time
- Microsoft Word
- Laboratory experience
- Continuous improvement
Actemium Automation Hampshire - Assistant Finance Business Partner
VINCI Energies —Waterlooville
- Full-time
- Accounting
- Annual leave
Contract Support Analyst
National Grid —Fareham
- £40,706.00 - £44,297.50 a year
- Microsoft Powerpoint
- Microsoft Word
- Presentation skills
6d
Risk and Policy Manager
Hampshire and Isle of Wight ICB —Eastleigh
- £57,528 - £64,750 a year
- Full-time
- Hybrid work
- Employee discount
- Sick pay
9d
Client Service Account Manager - Associate
JPMorganChase —Bournemouth
- Full-time
- Organisational skills
- Communication skills
MIS Officer
PETA —Portsmouth
- £30,000 - £35,000 a year
- Customer service
- Continuous improvement
- Organisational skills
- Free parking
- Annual leave

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information management system specialist jobs near southampton, eng

Principal Regulatory Affairs Specialist - EMEA (Cluster Partner)

CooperVision -
Southampton

Apply Now

Job details

Full-time

Qualifications

Microsoft Word
Document control
Driving Licence
Microsoft Outlook
Relational databases
Labelling
Computer literacy
Stakeholder liaison
Coaching
Mentoring junior staff
Filing
Internal department liaison
Analysis skills
Compliance management
Project management
Mentoring
Contingency planning
Organisational skills
Technical writing
Professional development mentoring
Networking
Document management
Document management systems
Communication skills
ISO 13485
Cross-functional communication
Corporate regulatory compliance oversight
Analytics

Full job description

Job title: Principal Regulatory Affairs Specialist - EMEA

Department: Regulatory Affairs

Location: Southampton, UK / Gorinchem, Netherlands or Gothenburg, Sweden

GLS: P04

Working hours: UK – 37.5 hours per week, Netherlands or Sweden – 40 hours per week

A brighter future awaits you

What to expect:

The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction across our UK&I, BeNeLux and Nordic Clusters, for products from concept to launch, and beyond into post market, as well as regulatory processes. The Principal RA Specialist articulates and executes the agreed regulatory strategy for assigned corporate projects. Leads the creation, development, and implementation of global/regional regulatory affairs procedures for marketed products and to maintain, update or remediate company’s regulatory compliance status.

Essential Functions & Accountabilities:

Registration Activity

Reviews and approves regulatory documents for the registration of current and new products in assigned markets.
Oversees the maintenance of submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Maintains, updates and remediates regulatory files and documents as required. This includes maintaining communication across the EMEA RA team and other departments, sites, or business units, to provide regulatory status reports.
Coaches/Mentors more junior team members with submission

Monitoring Registration Requirements within Region

Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing CooperVision products in a specified region.
Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners.
Analyses impact and communicate to management changes in regulations or requirements that have been identified.
Establish and leverage working relationships with government, regulatory agencies, and trade associations for the purpose of advocating CooperVision positions

Technical Documentation

Reviews compiled Technical Files for CE approval prior to submission
Supports RA Management with Notified Body requests for information.
As required, plays a significant role in technical audits in the UK, EU, ACE and MENA region, i.e. preparation, contingency planning, response, findings and close out activities.

Support to CooperVision Processes

Represents the perspective of regulatory affairs to the company.
Interprets general business objectives and effectively present information to manager and regions.
Reviews and approves product labelling. Initiates IFUs and other required product labelling in line with relevant UK, EU, ACE & MENA requirements.
Supports “Own Brand” and “Private label “customers and liaises with EU Competent Authorities and other Ministries of health as necessary
Provides input to Regulatory Affairs Impact Documents (RAIDS) from UK EU, ACE & MENA perspective.
Undertakes other administrative tasks to support CE marking and regional registrations.
Responsible for exhibiting professional behaviour with internal and external business associates that reflect positively on CooperVision, The individual conveys a trustworthy, credible, and reliable image at all times.
Act as a resource to the regions on quality issues and propose changes to minimise risks and enhance quality, reliability, safety and productivity.
Act as spokesperson, when appropriate, regarding CooperVision practices, public policy, business interests; arrange for technical explanations from internal or external experts.
Support RA compliance activities as necessary in assigned regions
Independently manage multiple projects, department initiatives and day to day tasks

About you:

Experience:

6-8 years of medical device regulatory experience.
Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
Medical device industry experiences including strong working knowledge and experience with MDD and MDR.
Ability to operate in a business-driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.
Must have the ability to build relationships and influence decision makers.
Comprehension of industry developments and changes in the political environment.
Extensive network-building and contact experience.
Capability to interact effectively and credibly at senior levels.
Experience in electronic document management systems

Knowledge, Skills and Abilities:

Understanding of ISO 13485 requirements and EU medical device regulations.
Ability to read and understand technical material.
Excellent attention to detail
Excellent organizational skills
Excellent written and verbal communication skills.
Excellent organizational skills.
Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system.
Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision.
Experienced at reviewing and approving product labelling.
Flexible and able to self-manage multiple priorities.
Able to work effectively in multinational/multicultural environments.
Flexibility to work across the UK sites

What we offer:

You’ll receive competitive compensation and a fantastic benefits package.

We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision.

If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

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Refine Your Search

information management system specialist jobs in southampton, eng

Principal Regulatory Affairs Specialist - EMEA (Cluster Partner)

Training Specialist

Chief Technology Officer (CTO)

Assistant Operations Manager

Customer Support Specialist (Customer Support Management)

Mission Operations Specialist - UK

Team Leader - Customer-Centric Ways of Working and Collaboration

Trade Compliance Specialist

ICT Technical Manager HIWFRS624695

Information Officer

Locality Administrator

Commercial Contract Specialist II

Conformity Assessment Procedure Specialist (CAPS) - UKCA & Global Regulatory Affairs Specialist

Logistics Supervisor (Fareham - Full Time - Logistics experience required)

Laboratory Programme Manager

Actemium Automation Hampshire - Assistant Finance Business Partner

Contract Support Analyst

Risk and Policy Manager

Client Service Account Manager - Associate

MIS Officer

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