Principal project manager Work, Jobs in East Cowes, Iow (with Salaries)

Principal Regulatory Affairs Specialist - EMEA (Cluster Partner)
CooperVision —Southampton
- Full-time
- Microsoft Outlook
- Computer literacy
- Analysis skills
Project Officer
University of Portsmouth —Portsmouth
- £19,248 - £34,610 a year
- Part-time
- Hybrid work
- University
- Mentoring
- Employee discount
3d
Supply Chain Principal
BAE Systems —Portsmouth
- £45,000 a year
- Management
9d
Assistant Project Manager
Bridges Electrical Engineers —Portsmouth
- Full-time
- Employee discount
- Referral programme
Quick apply
Business Development Manager
CDM Group —Hilsea
- £45,000 - £60,000 a year
- Full-time
- Sales
- Customer service
- Business development
- Free parking
- Gym membership
Quick apply
7d
Maintenance Manager
Manor Adventure —Bembridge
- £16 an hour
- Weekend availability
- Microsoft Outlook
- Maintenance
- In-person
- Free parking
Quick apply
7d
Principal Development Management Officer - Fixed term till 31st March 2028
New Forest District Council —Lyndhurst
- £53,179 - £58,748 a year
- Full-time
- Hybrid work
- Management
- Analysis skills
- Project management
- Annual leave
- Employee assistance programme
6d
Project Manager
Gallifordtry —Havant
- Full-time
- Engineering
- Microsoft Office
- Bachelor's degree
- Employee assistance programme
- Employee discount
Project Manager (Temporary Contract)
TÜV SÜD —Fareham
- Temporary
- Laboratory experience
- Microsoft Office
- Employee assistance programme
6d
HR & Payroll Assistant
Lane Clark & Peacock —Winchester
- Continuous improvement
- Human resources
- Contracts
- Annual leave
- Employee discount
Project Planner
Bridges Electrical Engineers —Portsmouth
- Full-time
- Hybrid work
- Project management
- Contracts
- Employee discount
- Referral programme
Quick apply
Principal Product Safety Engineer Radars
BAE Systems —Portsmouth
- £60,000 a year
- Mentoring
- Leadership
3d
Senior / Principal Transport Consultant - Liveable Places
WSP —Southampton
- Part-time
- Hybrid work
- Engineering
- Communication skills
- Flexitime
- Work from home
Technical Transport Planner
Portsmouth City Council —Portsmouth
- £32,061 - £36,363 a year
- Hybrid work
- Analysis skills
- Travel
- Communication skills
2d
Site Manager
Gallifordtry —Chichester
- Full-time
- Microsoft Excel
- Analysis skills
- Construction experience
- Employee assistance programme
- Employee discount
Deputy Site Manager (Secondary School)
Kings' School —Winchester
- £27,780 a year
- Full-time
- In-person
- School
- Free parking
- Health & wellbeing programme
Quick apply
3d
Senior/Principal/Associate Civil/Structural Engineer
Ramboll —Southampton
- Full-time
- Civil engineering
- Engineering
- Master's degree
Quick apply
Estimating Engineer
Senior Flexonics LPE —Lymington
- Full-time
- CAD
- Engineering
- Microsoft Office
- Free parking
- Profit sharing
Quick apply
Principal Firmware Engineer
Microchip Technology —Whiteley
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
MEICA Lead - Southern Water
Gallifordtry —Chichester
- Full-time
- Engineering
- Microsoft Office
- Master's degree
- Employee assistance programme
- Employee discount
2d

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Principal Regulatory Affairs Specialist - EMEA (Cluster Partner)

CooperVision -
Southampton

Apply Now

Job details

Full-time

Qualifications

Driving Licence
Microsoft Outlook
Relational databases
Computer literacy
Analysis skills
Organisational skills
Technical writing
Agile
IT
Document management systems
Communication skills

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

principal project manager jobs in east cowes, iow

Principal Regulatory Affairs Specialist - EMEA (Cluster Partner)

Project Officer

Supply Chain Principal

Assistant Project Manager

Business Development Manager

Maintenance Manager

Principal Development Management Officer - Fixed term till 31st March 2028

Project Manager

Project Manager (Temporary Contract)

HR & Payroll Assistant

Project Planner

Principal Product Safety Engineer Radars

Senior / Principal Transport Consultant - Liveable Places

Technical Transport Planner

Site Manager

Deputy Site Manager (Secondary School)

Senior/Principal/Associate Civil/Structural Engineer

Estimating Engineer

Principal Firmware Engineer

MEICA Lead - Southern Water

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