IVD Coordinator Job at Four Seasons (Deroches Island)

New

Director, Diagnostics

This Diagnostic Lead role will implement Dx development GSK Development wide enc...

Location

United States; United Kingdom , Collegeville; Stevenage; Waltham; Upper Providence

Salary:

189750.00 - 316250.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Ph.D. in Biological Sciences and 5 years of pharmaceutical and/or diagnostic industry experience or B.S or M.S. with 7 years of pharmaceutical and diagnostic industry experience
Experience in drug / diagnostic development especially late stage development, regulatory approval and life cycle management (eg follow on Dx)
Experience with technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
Experience in IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements
Experience performing due diligence and audit of Dx developers
Experience with GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
Experience with QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
Experience with clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)
Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams

Job Responsibility

Manage the team of associate directors, diagnostics. Team manager to deliver on the vision of equipping GSK to be a leader in oncology through Dx development driving the portfolio value
Monitor and report projects progress, outcomes, KPIs eg delivery of Target Diagnostic Profile
Remove barriers to Dx strategy development and implementation, collaborating cross functionally with clinical operations, external engagement, procurement, etc…
Exhibits timely management and delivery of projects/work streams within agreed budget
Must be able to manage multiple projects and work streams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives
Clearly and concisely report project progress and outcomes, coordinating with project management, finance and business operations
Ensure learnings and best practices are shared and adopted for effective delivery
Participate in the evaluation of advanced technologies for IVD and clinical biomarker development
Keep a pulse on team execution and cross-functional ways of working with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams
Provides frequent project status updates / reports related to Dx deliverables

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

Staff Scientist I

We are seeking a candidate who can bring experience of clinical flow cytometry w...

Location

United States , San Diego

Salary:

124700.00 - 205800.00 USD / Year

BD

Expiration Date

Until further notice

Requirements

Minimum Master’s degree or Ph.D. degree in biological science and a combination of education and experience in product development
Minimum 5 years of demonstrated experience in R&D or clinical/research laboratory environment
Experience in IVD product development is required
Strong, proven product development knowledge of processes, measures, etc. (phase gated development systems)
Knowledge of biostatistical methods and data analysis experience is required
Proven experience of working in cross-functional product development teams

Job Responsibility

Work with team members and lead collaborations across teams on crafting experimental approaches for new reagent and assay development
Maintain strong understanding of innovative science and technology development in the industry
Deliver clinical projects on schedule and within specification
Work with leadership team members and product development teams to improve time to market by reducing product development life cycle and improving the product development process
Prepare technical reports, summaries, protocols, and analyses of R&D projects
Work on issues where analysis of situation or data requires review of relevant factors
Exercise judgement within defined procedures and policies to determine appropriate action
Effectively coordinate with other functional areas associated with the R&D activities
Assure compliance with all local, state, federal, and BD policies/ procedures regulations associated with quality, regulatory, safety, etc.

Fulltime

Vice President, Diagnostics

We are looking for a senior commercial person with significant experience of In ...

Location

United Kingdom , Cambridge

Salary:

Not provided

Osprey CSL

Expiration Date

Until further notice

Requirements

Degree qualifications to Masters/PhD level from an Engineering or Science background preferred
MBA would be beneficial
Experience of IVD/LSRT development
Understanding and experience of the development of microfluidics, optics, sample preparation techniques, NGS technologies or single cell workflows
You will have carried out a similar role in another fee-for-service business in either a commercial role or a client-facing Programme Management role
Approximately 10+ years post education work experience
Experience of operating at a senior level (CXO, VP or R&D Director) within large blue chip corporates and startups
Experience in delivering against defined sales and business development targets
Evidence of success in building a rapport and trust in IVD and LSRT customers
Experience of new product/device introduction

Job Responsibility

Account management, within a set of nominated key accounts: Act as main point of contact between Sagentia Innovation and client account
Network widely to maximize exposure to Sagentia Innovation within the client’s organization
Seek opportunities within target accounts to grow additional revenue streams for Sagentia Innovation
Maintain sales and revenue forecast
Responsible for client communication on commercial matters
ensure issues are addressed that are raised by the client or by Sagentia Innovation
Business Development within the IVD and LSRT industry: Collaborate with Business Development Managers within the Group
source new sales leads through proactive sales & marketing activities
Visit prospects to identify potential client needs sell the value proposition of Sagentia Innovation
Own and coordinate the writing and delivery of compelling sales & marketing material (e.g. discussion documents, proposals, case studies, capability decks)

What we offer

We offer a highly competitive salary and benefits package
We are committed to career development and make a focused effort to offer bespoke training and mentoring to allow each individual to thrive within their environment and realise personal potential

Fulltime

New

Regulatory Affairs Officer

Our client is a leading organisation in the healthcare and diagnostics sector, c...

Location

United Kingdom , Edinburgh

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

A relevant degree or equivalent experience in regulatory affairs
Previous experience in regulatory submissions and compliance within medical devices or related industries
Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions
Excellent technical writing skills and proficiency in MS Office
Ability to work independently and collaboratively in a fast-paced environment
Exceptional attention to detail, time management, and problem-solving skills

Job Responsibility

Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others
Advise internal teams on data requirements for successful license applications
Develop and maintain product labelling requirements and liaise with stakeholders
Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards
Maintain technical files and regulatory documents for multiple territories
Communicate effectively with regulatory authorities and external bodies
Support process improvements and provide guidance and training to team members

Fulltime

Regulatory Affairs Officer

As a Regulatory Affairs Officer, you will be responsible for developing regulato...

Location

United Kingdom , Edinburgh

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

A relevant degree or equivalent experience in regulatory affairs
Previous experience in regulatory submissions and compliance within medical devices or related industries
Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions
Excellent technical writing skills and proficiency in MS Office
Ability to work independently and collaboratively in a fast-paced environment
Exceptional attention to detail, time management, and problem-solving skills

Job Responsibility

Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others
Advise internal teams on data requirements for successful license applications
Develop and maintain product labelling requirements and liaise with stakeholders
Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards
Maintain technical files and regulatory documents for multiple territories
Communicate effectively with regulatory authorities and external bodies
Support process improvements and provide guidance and training to team members

Fulltime

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Technical Support Transplant Europe – Clinical Marketing

This role combines advanced technical application expertise with strong clinical...

Location

Spain

Salary:

Not provided

werfen

Expiration Date

Until further notice

Requirements

Advanced degree in Biomedical Sciences, Immunology, or related field
specialization in HLA / histocompatibility / transplant highly preferred
Minimum 5 years of experience in the IVD, transplant, or immunogenetics field, ideally in roles combining clinical, technical, and marketing responsibilities
Deep understanding of transplant diagnostics, HLA typing, antibody testing, and related workflows
Strong knowledge of clinical applications, assay interpretation, and lab operations
Experience with health economics, clinical evidence generation, and case study development is a plus
Proficient in complaint management systems and customer satisfaction testing
Excellent communication and relationship-building with clinical and scientific stakeholders
Ability to translate complex clinical and technical concepts into value-driven marketing and training strategies
Strategic thinker with operational agility

Job Responsibility

Act as second-level technical, scientific, and application support for the Transplant portfolio across all European affiliates
Manage complaint and non-complaint cases for all products within the Transplant portfolio
Provide technical assistance to support the completion of sales processes
Initiate and monitor corrective and preventive actions (CAPAs)
Maintain continuous communication with affiliates
Enhance customer support excellence by promoting best practices
Contribute to User Acceptance Testing (UAT) for new product releases
Provide clinical expertise and strategic guidance on the integration and use of Transplant solutions
Work closely with KOLs, affiliates, Scientific Affairs and Market Access to design and coordinate clinical studies
Establish, strengthen, and expand relationships with Key Opinion Leaders (KOLs) and scientific societies

Fulltime

New

Receptionist

We are seeking a friendly and professional Receptionist to join our Tamayyaz Pro...

Location

Saudi Arabia , Riyadh

Salary:

Not provided

Fairmont Grand Del Mar

Expiration Date

Until further notice

Requirements

Saudi nationality (Tamayyaz Program is for Saudi Nationals Only)
High school diploma or equivalent
Little to no work experience required
fresh graduates or those with up to 6 months of relevant experience are encouraged to apply
Basic English language skills
Strong passion for the hospitality industry
Excellent interpersonal and communication skills
Team player with a collaborative attitude
Detail-oriented and organized approach to work
Ability to work a flexible schedule, including evenings, weekends, and holidays

Job Responsibility

Greet and welcome guests in a professional and friendly manner
Handle check-ins and check-outs efficiently, ensuring a smooth experience for guests
Manage reservations and respond to inquiries via phone, email, and in person
Provide information about hotel services, local attractions, and amenities
Coordinate with other departments to meet guest needs and maintain high service standards
Process payments and handle cash transactions accurately
Assist with administrative tasks such as filing, data entry, and report generation
Maintain a clean and organized front desk area
Address and resolve guest concerns promptly and professionally
Stay updated on hotel policies, promotions, and events to provide accurate information to guests

What we offer

Competitive salary and benefits package
Professional growth opportunities within Accor Group
A dynamic and supportive work environment
Employee discounts and exclusive hospitality benefits

Fulltime

IVD Coordinator

Four Seasons

Location:
Seychelles , Deroches Island

Category:
Hospitality and Tourism

Contract Type:
Not provided

Salary:

Job Description:

Requirements:

Additional Information:

Job Posted:
January 20, 2026

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