Senior Vigilance Specialist

1 month ago

Chester, United Kingdom Sinclair Pharma Full time

Sinclair are currently recruiting for Senior Vigilance Specialist at their Chester office. The Senior Vigilance Specialist will be a member of the Vigilance Team and will report to the Vigilance Manager. This position assures regulatory compliance and transparency of post-market surveillance, complaints and adverse events within the organisation, in line with global policies, procedures, and applicable regulations.

The Senior Vigilance Specialist will work closely with the Legal Manufacturers to manage the completeness and closure of complaints, adverse events and Field Safety Corrective Actions. This position is responsible for the triage, communications and reporting to the EU Member State National Competent Authorities and other global regulators.

**Hours of work: 37 hours (Monday to Friday)**

**Location: Chester Business Park, Chester, CH4 9QT**

**About Sinclair**

Our people embody being the best, mirroring our product and industry values to be the very best versions of themselves. We essentially have our own language for people power. Self-owned and driven by our incredible world of passionate people.

Sinclair exists to create confidence Confidence in our products, for our customers and of course, for our people. Our business is on a journey to become the dominant player in strategic global locations, rivalling our competition with diverse product development, by 2026.

Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

**The Role**
- To manage Customer Complaints, Post Market Surveillance and Periodic Safety Update Report activities.
- Preparation, review, and submission of Post Market Surveillance Data, including PMS Tracking, leading PMS Board Meetings, producing PMS/PSUR Reports, PMCF Plans and PMCF Evaluation Reports, and complaint trending.
- Ensuring Vigilance and Post Market Surveillance data is administered in a timely manner in EUDAMED
- To support responses to the National Competent Authorities and Regulatory Agencies in relation to Adverse Events and Field Safety Corrective Actions
- Assist and support of any Field Safety Notices or Corrective Actions generated by the Company or a 3rd party manufacturer.
- Working with Manufacturing and Research and Development departments across all the Manufacturing entities to ensure problems are effectively resolved and investigations are fully documented. Instigate and implement effective corrective and preventive actions.
- Reporting to Vigilance Manager on the effectiveness of the vigilance processes within the Quality Management System and any needs for improvement
- To ensure compliance to all applicable quality standards, regulations and internal procedures by proactively interpreting Vigilance requirements, and devising and implementing solutions to support the maintenance and enhancement of the Quality Management System and quality documentation throughout the business
- Travel to Manufacturing sites, training workshops and other company events may be required to support the Vigilance processes
- Support management with claim and litigation cases
- Support internal and external audits, change controls, artwork review, liaison with Compliance, Sales and Marketing departments.
- Deputise for Vigilance Manager as required.

**Your Skills & Experience - Do You Have What it Takes?**

Essential:

- Minimum 3 years’ experience in Quality Assurance (Medical Device Vigilance) within a Medical Device or Aesthetics organisation
- Working knowledge of the Medical Device Regulation and Medical Device Directive
- Knowledge of other vigilance legislation and guidelines, e.g., US, Canadian regulations
- Direct interaction with EU Member State National Competent Authorities and other global regulators
- Excellent attention to detail when reviewing and preparing documentation
- Organised, target-orientated, flexible, good time management skills
- Strong written and oral communication skills
- Excellent attention to detail when reviewing and preparing documentation
- Fluency in written and spoken English

Desirable:

- University Degree in a scientific field
- Experience working across export markets and interacting with international distributors
- Specific knowledge in dermatology/aesthetics
- Experience working with drug/device combination products
- Experience of relating clinical information to device function and cause assessment.
- Experience of root cause analysis, including use of common tools

**A bit about you - do you fit this description?**

**Role competencies**:

- Personal responsibility
- Communication, impact and influence
- Analytical and critical thinking capacity
- Time manag

  • Customer Service Specialist

    4 days ago

    Chester, United Kingdom Charterhouse Recruitment Services Full time

    **CUSTOMER SERVICE SPECIALIST (FINANCIAL SERVICES)** We are delighted to again be working with our client based in Chester who are looking to expand their team a Customer Service Specialist. Our client is a unique and growing business within the financial services sector, and they have ambitious growth plansfor 2023 so the successful person will be given...

  • Audit Senior

    2 weeks ago

    Chester, United Kingdom Hays Specialist Recruitment Limited Full time

    Your new firmA Top 20 chartered accountancy practice is seeking to appoint an Audit Senior into their growing Chester office. This firm provides a range of accountancy, audit and business advisory services to their expanding client base across the North West. This is a great opportunity for a candidate to join a successful firm which values its workforce...

  • Specialist TA

    3 weeks ago

    Chester, Cheshire, United Kingdom Oakleaf Partnership Full time

    Talent Acquisition Specialist £12 month contract Financial Services 3 days a week in the office Oakleaf Partnership North are seeking a Talent Acquisition Specialist to join our global client on a 12 month contract covering maternity leave in the team. As the Talent Acquisition Specialist, you will be responsible for partnering with recruiters and hiring...

  • Specialist TA

    3 weeks ago

    Chester, Cheshire, United Kingdom Oakleaf Partnership Full time

    Talent Acquisition Specialist £12 month contract Financial Services 3 days a week in the office Oakleaf Partnership North are seeking a Talent Acquisition Specialist to join our global client on a 12 month contract covering maternity leave in the team. As the Talent Acquisition Specialist, you will be responsible for partnering with recruiters and hiring...

  • Specialist, Order Management

    1 month ago

    Chester, United Kingdom Bristol Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • TA Specialist

    3 weeks ago

    Chester, Cheshire, United Kingdom Oakleaf Partnership Full time

    Talent Acquisition Specialist £160 per day 12 month contract Financial Services Chester 3 days a week in the office Oakleaf Partnership North are seeking a Talent Acquisition Specialist to join our global client on a 12 month contract covering maternity leave in the team. As the Talent Acquisition Specialist, you will be responsible for partnering with...

  • TA Specialist

    3 weeks ago

    Chester, Cheshire, United Kingdom Oakleaf Partnership Full time

    Talent Acquisition Specialist £160 per day 12 month contract Financial Services Chester 3 days a week in the office Oakleaf Partnership North are seeking a Talent Acquisition Specialist to join our global client on a 12 month contract covering maternity leave in the team. As the Talent Acquisition Specialist, you will be responsible for partnering with...

  • Senior Tax Specialist

    2 weeks ago

    Chester, Cheshire, United Kingdom Connect Recruit - Most trusted Multi-Sector Recruitment Agency 2023- England & Wales Full time

    Job Description Experienced Tax Specialist Wanted Are you ready to dive into a dynamic role where your expertise meets cutting-edge tax regulations? We're seeking a savvy Tax Specialist to lead the charge in delivering top-tier tax services, ensuring compliance with laws and regulations while exceeding client expectations. As our Tax Specialist,...

  • Senior Tax Specialist

    1 week ago

    Chester, Cheshire, United Kingdom Connect Recruit - Most trusted Multi-Sector Recruitment Agency 2023- England & Wales Full time

    Experienced Tax Specialist Wanted Are you ready to dive into a dynamic role where your expertise meets cutting-edge tax regulations? We're seeking a savvy Tax Specialist to lead the charge in delivering top-tier tax services, ensuring compliance with laws and regulations while exceeding client expectations. As our Tax Specialist, you'll be the driving...

  • Specialist, Customer Service

    4 weeks ago

    Chester, United Kingdom Bristol Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Customer Service Specialist

    4 weeks ago

    Chester, United Kingdom Bristol Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Autism Assessment Specialist

    1 month ago

    Chester, United Kingdom Countess of Chester Hospital NHS Foundation Trust Full time

    **Working Full time**: 37.5 hours per week Autism Assessment Specialist & ASD Pathway Coordinator "Assistant Psychologists/Psychologists or Specialist Speech & Language Therapists are all encouraged to apply." An exciting opportunity has arisen for an enthusiastic, highly motivated and dynamic Autism Assessment Specialist & Pathway Coordinator within our...

  • Accounts Semi Senior

    3 days ago

    Chester, United Kingdom Clark Wood Full time

    Accountancy Practice recruitment specialists Clark Wood are currently working with an independent firm of chartered accountants in Chester who are looking to recruit an accounts assistant/semi senior to the team. Competitve Salary - Hybrid working options/Chester office - annual bonus - full or part time considered As an Accounts Assistant / Accounts Semi...

  • Talent Acquisition Associate/Specialist

    2 weeks ago

    Chester, United Kingdom Pontoon Remote Work Freelance Full time

    Job Title: Talent Acquisition Associate/Specialist (12 month FTC)Location: Chester Our well renowned banking client is currently on the market for a Talent Acquisition Associate/specialist, the role is a hybrid role (3 days in 2 days from home). The position is a 12-month contract. Location Overview:Find us in the city of Chester, a destination renowned for...

  • Talent Acquisition Associate/Specialist

    2 weeks ago

    Chester, United Kingdom Pontoon Full time

    Job Title: Talent Acquisition Associate/Specialist (12 month FTC)Location: Chester Our well renowned banking client is currently on the market for a Talent Acquisition Associate/specialist, the role is a hybrid role (3 days in 2 days from home). The position is a 12-month contract. Location Overview:Find us in the city of Chester, a destination renowned for...

  • Talent Acquisition Associate/Specialist

    2 weeks ago

    Chester, United Kingdom Pontoon Full time

    Job Title: Talent Acquisition Associate/Specialist (12 month FTC)Location: Chester Our well renowned banking client is currently on the market for a Talent Acquisition Associate/specialist, the role is a hybrid role (3 days in 2 days from home). The position is a 12-month contract. Location Overview:Find us in the city of Chester, a destination renowned for...

  • Senior / Chartered Building Surveyor

    4 weeks ago

    Chester, United Kingdom Bennett and Game Recruitment LTD Full time

    Our client, an well established and growing multi-disciplinary Consultancy, are looking for a Senior / Chartered Building Surveyor to join them, based from their Chester / Manchester office due to continued growth with a strong pipeline of work in place. The company are specialists in solving complex building, construction and property issues for commercial...

  • Accounts Senior

    1 month ago

    Chester, United Kingdom Taylor Rose Recruitment Full time

    Full Time or Part Time, Permanent - Chester, Cheshire - Posted 3 hours ago Accountancy Practice specialists Taylor Rose Recruitment are working with a progressive firm in Chester who, due to continued growth are seeking an Accounts Senior to join their Business Services team. This is a great opportunity for an ACCA/ ACA Qualified individual (PQ or MAAT...

  • Senior / Chartered Building Surveyor

    4 weeks ago

    Chester, United Kingdom Bennett and Game Recruitment Ltd Full time

    Our client, an well established and growing multi-disciplinary Consultancy, are looking for a Senior / Chartered Building Surveyor to join them, based from their Chester / Manchester office due to continued growth with a strong pipeline of work in place. The company are specialists in solving complex building, construction and property issues for commercial...

  • Senior / Chartered Building Surveyor

    4 weeks ago

    Chester, United Kingdom Bennett and Game Recruitment LTD Full time

    Our client, an well established and growing multi-disciplinary Consultancy, are looking for a Senior / Chartered Building Surveyor to join them, based from their Chester / Manchester office due to continued growth with a strong pipeline of work in place. The company are specialists in solving complex building, construction and property issues for commercial...