IVD Coordinator Job at Four Seasons (Deroches Island)

Regulatory Affairs Specialist / Manager (CDx)

Join the SOPHiA GENETICS Global Regulatory Affairs Team as a Regulatory Affairs ...

Location

United States , Boston

Salary:

71000.00 - 168000.00 USD / Year

SOPHiA GENETICS

Expiration Date

Until further notice

Requirements

5-8 years' Regulatory Affairs experience within Diagnostics and/or Medical Devices (complex Class II / Class III)
Practical experience contributing to FDA submissions for diagnostic and/or software medical devices (e.g. Q-Subs, 510(k), De Novo, PMA or supplements), with tangible involvement in drafting or compiling submission content
Background in diagnostics (CDx and/or broader IVD) with an understanding of NGS and/or software as a medical device highly beneficial
Experience interacting with Health Authorities (e.g. FDA) essential
exposure to additional global agencies (e.g. Health Canada, TGA, PMDA or EU Notified Bodies) highly beneficial
Familiarity with global regulatory requirements for diagnostics and an interest in expanding knowledge into new regions and evolving frameworks
Success-orientated and solutions-focused mindset that embraces team collaborations, change, growth and inclusion
Full fluency in English

Job Responsibility

Provide strategic and operational regulatory support for diagnostic and CDx products, including software-based and other complex IVD medical devices
Drive and coordinate the development and execution of US FDA and global regulatory strategies and submission plans (e.g. Q-Subs, 510(k), PMA, and equivalent pathways) to support timely product clearances and approvals
Contribute to the drafting, review, and compilation of regulatory submissions and responses, collaborating closely with clinical, quality, R&D, and commercial teams
Support interactions with regulatory authorities (e.g. FDA and other key agencies) and act as a central point of contact for CDx/IVD regulatory topics across internal stakeholders

What we offer

Outstanding Medical, Dental & Vision with 90% Employer Contribution
Company matched 401K at 4%
Company-paid short & long-term disability insurance
FSA commuter benefits
20 Days PTO, increasing to 25 with tenure
5 Days Sick and 14 Public Holidays
Free EAP

HelpLine Support Manager

The HelpLine Support Manager will lead a group of specialists responsible for pr...

Location

Spain

Salary:

Not provided

werfen

Expiration Date

Until further notice

Requirements

Degree in Science, Engineering or Technology
Minimum 3 years’ experience coordinating specialised teams
In-depth knowledge of IVD Haemostasis products
High command of English
Customer-oriented and experienced in technical service environments
Knowledge of IVD Laboratory products (instruments and reagents)
Knowledge of of clinical laboratory workflows, quality controls, and regulatory standards in in vitro diagnostics
Previous experience in corporate/global marketing and Database tools
Basic knowledge of Portuguese
Excellent interpersonal skills and a collaborative management style

Job Responsibility

Directly manage the Application Support team for Hemostasis products
Act as a technical resource when required, providing advanced troubleshooting and direct contact to Customers
Plan resources, organise 24x7 on-call shifts and ensure operational coverage
Monitor SLAs, KPIs and implement continuous improvement actions
Coordinate with other Managers (HelpLine, IT Support) to optimise processes, resolve incidents and build strategies within our department
Participate in strategic projects and cross-functional initiatives
Ensure compliance with quality, regulatory and security policies
Assure high standards in Customer Service satisfaction, quality and results
Collaborate with Sales, QA, IT Corporate and other departments to maintain smooth communication and alignment of objectives
Manage and drive internal projects under its own supervision

Fulltime

Regulatory Affairs Specialist II

On behalf of our client, a leading manufacturer and seller of products for the l...

Location

United States , Irvine

Salary:

45.00 - 50.00 USD / Hour

Tucker Parker Smith Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Biochemistry, Biology, Medical Technology, or a related field
3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
Knowledge of FDA and CE marking requirements for IVD products strongly preferred
Strong ability to work both independently and in a collaborative environment
Excellent communication skills, with the ability to negotiate and persuade effectively
Proven analytical, problem-solving, critical thinking, and computer skills
In-depth understanding of Regulatory Affairs policies, practices, and procedures

Job Responsibility

Revise assigned technical files using the latest templates to ensure clarity and compliance with IVDR requirements, including incorporation of technical reports, validations, and test data
Meet pre-defined timelines and actively participate in multiple weekly meetings to address issues, answer questions, and provide progress updates to the project manager
Support the IVDR labeling conversion project by updating specifications, tracking logs, and collaborating cross-functionally to ensure compliance
Monitor monthly manufacturing schedules, product fill dates, lot numbers, and change requests for accurate labeling updates
Manage un-CE Marking of selected products and track changes until final labeling reflects updated specifications
Maintain technical file tracking logs and notify regional RA teams of labeling changes
Coordinate with the RA SAP restriction coordinator to restrict specific product lots when required

Director, Precision Medicine and Diagnostics Quality

In this vital role you will report to the Executive Director, Precision Medicine...

Location

United States

Salary:

198507.00 - 229864.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience
Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience
Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience
At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Develop collaborative partnerships with Research and Development (R&D) Leadership to define the state of quality and potential areas of quality risk exposure for Amgen’s In-Vitro Diagnostic use within Precision Medicine studies
Develop innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs, including oversight of partners, suppliers, and service providers that are critical to Amgen’s efforts to reach the right patients at the right time and dosage
Provide quality leadership in a matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations
Develop and implement IVD quality management strategies (including risk-based regulatory approaches) that ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the EU and US
Partner with leadership teams and key stakeholders to develop/ monitor metrics (KQI, KPI leading and lagging) for critical to quality IVD and Precision Medicine processes that aim to identify risks and areas needing improvement at key oversight forums (e.g. management reviews)
Coordinate and collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution and support of regulatory filings
Maintain up-to-date knowledge of IVD regulations and applicable guidance
Provide risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management)
Ensure that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards
Oversee the management of IVD-related QMS elements related to business procedures including the development and execution of the process and audit program, and the support of Inspections by Health Authorities or notified bodies

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

F&B Reservations and Experience Coordinator

Ladies and Gentlemen who embody the spirit of Nekajui, a Ritz‑Carlton Reserve, s...

Location

Costa Rica , Papagayo

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Previous experience (1–2 years) in luxury hospitality, fine dining restaurants, guest experience coordination, or reservations management
Experience managing culinary or in‑residence dining experiences, including private chef services or bespoke events
Prior use of OpenTable or other advanced reservation platforms, ideally in a high‑end or luxury environment
Full professional proficiency in English and Spanish, both spoken and written
Strong proficiency in Opera, GXP, Microsoft 365, and digital communication platforms
Basic skills in design or visual‑creation tools (e.g., Canva, Adobe Illustrator, or light photo editing)
Familiarity with luxury hospitality standards, Forbes service principles, and personalized guest experience methodologies
Demonstrated ability to deliver anticipatory, personalized, and emotionally engaging service
Strong cultural awareness and the ability to interact gracefully with high‑profile guests
High level of poise, emotional intelligence, and discretion

Job Responsibility

Serve as the primary point of contact for all restaurant reservations and Food & Beverage inquiries
Coordinate and confirm all dining reservations
Manage and orchestrate all in‑residence culinary experiences
Ensure clear, real‑time communication with Restaurants, Culinary, IVD, Guest Experience, Pre‑Arrival, and Residences Services
Identify and anticipate guest preferences, allergies, and special needs
Provide elegant and timely follow‑up on celebrations, dietary needs, custom menus, or private Residence experiences
Ensure all outgoing information is accurate, updated, and consistent
Maintain continuous communication with Guest Experience and Pre‑Arrival teams
Lead the use, accuracy, and optimization of OpenTable
Identify enhancement opportunities to elevate the guest experience and contribute to revenue

Fulltime

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

Associate Product Manager, Autoimmunity

Supports the Product Manager or the Marketing Director in the definition and imp...

Location

United States , Bedford

Salary:

90000.00 - 120000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Knowledge in Life Sciences: Medical Technology, Biology, Biotechnology, Chemistry
Bachelor's degree in biological science, business administration or marketing discipline, or equivalent
Minimum of 1 year prior experience in one of the following positions in the healthcare industry, preferably in the IVD sector: R&D
marketing product specialist
sales
medical technologist in clinical laboratories
Strong verbal and written communication skills
Able to work well with diverse groups of people

Job Responsibility

Marketing interface with R&D, Operations and QA/RA
Prepares and coordinates marketing support programs
Contribute to planning and creation of advertising and promotional materials
Write technical bulletins and newsletters
Keeps informed about developments in medical instrumentation/diagnostic industry as they apply to the company's future marketing plans
Provides sales technical training for sales staff
Works with field sales staff to develop training requirements and sales tools required to introduce new products and sales campaigns for all or part of product line
Makes presentations to customers
Understands all maintenance, performance and advantages of Werfen products
Understands technical aspects of Werfen and competitive products

What we offer

Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation and sick leave
Commission plan (for sales roles)
Performance-based bonus (for management and select professional roles)

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

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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