RA Manager Job at Eitan Medical (Netanya)

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...

Location

United States , Franklin Lakes

Salary:

59.00 - 63.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
Medical device and international registration experience is a must
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
Strong project management and communication (verbal, written) and skills
Able to independently handle multiple tasks/projects with minimum supervision
Self-starter with the ability to take over responsibilities
Team player, Attention to details, Highly result-oriented
Flexible and reliable personality
ability to manage stressful situations
High personal integrity and ethical standards

Job Responsibility

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Identify ways to improve the efficiency of current work process and best practices as necessary.

What we offer

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.

Fulltime

Qa Engineer

For our client – worldwide leader in innovative IT and networking technologies –...

Location

United States , Columbia

Salary:

Not provided

Flint International

Expiration Date

Until further notice

Requirements

Bachelor’s Degree (CS, EE), or equivalent experience required
4-6years of industry experience in coding in testing and test methodologies
Strong in QA process, process definition and execution
Strong working knowledge on test automation tools for back end/UI
Strong working knowledge of agile/waterfall SW methodologies
Strong QA Process
Work experience on one or more Test Automation tools (Cucumber, Postman, test Ng, Selenium)
Work experience Scripting Language (python)
Strong written and oral English communication skills
Process oriented, self-starter, self-motivated individual

Job Responsibility

Understand the overall project, understand phase-wise requirements
Involve in requirements gathering, analysis and definition
Understand test planning strategy
Regression strategy, non-functional testing
Functional testing post integrations customizations patches
Staging through lab/test, pre-production, production
Test automations
Generate and own User guides for integrations
Work on testing tasks for phases/integrations
Automate testing using test tools, scripts

Local Regulatory Affairs Manager Scandinavia

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...

Location

Norway , Oslo

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Science
Solid understanding of regulatory requirements and legal frameworks in Norway
Minimum 5 years of experience in Pharmaceuticals is a must
Experience with artwork maintenance and label requirements
Strong cross-functional collaboration across Scientific Affairs, Operations, Commercial, and external stakeholders
Solid working relationship/experience with regulatory authorities, experience with the Norwegian authorities is a plus
Fluent in Norwegian and English
Strong communicator, both written and verbal
Proactive, service-minded, and solutions-oriented
Commercially aware, with a business-driven approach to regulatory challenges

Job Responsibility

Ensure timely planning, preparation, submission and follow-up of regulatory activities in Norway on all classifications tasks such as: Life cycle management of Pharma products
Handle communication with different authorities as needed
Reviewing AW's and, as needed, commercial material
Lead local projects from a Regulatory Affairs perspective, connecting the dots across functions and markets
Giving key input on how to clear a path of access to the market for various products
Overseing local roll-out of Global NPDs/EPDs/GeoX projects
Do Smart risk assessment - to balance both the needs of our great commercial colleagues and compliance
Secure compliance in Veeva RIM system and GLAMS AW system (artwork)
Ensure product information, translations, and artwork meet regulatory requirements
Keep national databases and product monograph websites updated

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Team leader (operations)

Location

Salary:

Not provided

Flexisales Marketing Pvt. Ltd.

Expiration Date

Until further notice

Requirements

5+ years of Experience in Team Handling
Any Graduate
Post-Graduation Not Required
Looking to manage International B2B process
Ready to work in flexible shifts
Excellent verbal and written communication skills
Excellent interpersonal skills, with the ability to communicate with and relate to all levels both within and outside the organization
Should be dynamic, energetic, assertive besides excellent communication and presentation skills

Job Responsibility

Ensure completion of sales Process in place and Productivity
Ensures that company’s everyday activities run smoothly
Keep a track of how efficiently and effectively the organization is operating
Determine staffing requirements, and interview, hire and train new employees
Should have experience in handling team of 20 RA’s
Responsible for Performance management
Meeting the targets aligned
Quality Check of Team Members Performance and Share Feedback accordingly
To Provide Training to New Joiners as Required
To Supervise Team Adherence and Compliance are as per the Policies

Manager, Regulatory Global Labeling

This position will be responsible for leading the development, review, and manag...

Location

United States , San Rafael

Salary:

108000.00 - 162000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
2+ years in Regulatory Affairs
Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
US and/or EU Labeling experience minimally required and core labeling experience highly desired
Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
Experience with E2E global labeling processes and management of Company Core Data Sheets
Experience in review process, standards, and industry best practice pertaining to labeling
Strong scientific background and/or experience
Working knowledge of medical terminology and drug safety

Job Responsibility

Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
Ensure appropriate labeling strategies are communicated to project teams
Ensure labeling is compliant with core labeling and local regulations
Ensure labeling is accurate and of the highest quality
Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
Lead the assigned product labeling teams (PLTs) and support labeling positions
Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Regulatory Affairs Specialist

Join a top-tier global healthcare leader with a stable, inclusive, and professio...

Location

Japan , Tokyo

Salary:

4000000.00 - 8000000.00 JPY / Year

Randstad

Expiration Date

November 30, 2026

Requirements

Strong English and Japanese communication skills (written and verbal)
Experience in Regulatory Affairs for IVD or Medical Devices
typically 2+ years preferred, but equivalent experience considered
Ability to collaborate effectively with cross-functional teams
Understanding of regulatory requirements for IVD/Medical Devices
Basic understanding of ISO 13485 and global QMS principles
High attention to detail and strong documentation management skills

Job Responsibility

Work as a Legal Manufacturer RA, driving global market access directly from Japan
Engage in cross-border projects using English daily within a dynamic factory RA team

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

New

Clinical Research Associate II

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Substantial start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval and Site activation
Update and maintain appropriate Clinical Trial Management System (CTMS) in a timely manner

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

South Korea , Seoul; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Strong problem solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks, and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise
Strong ability to make appropriate decisions in ambiguous situations
Willingness to work in a matrix environment and to value the importance of teamwork

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities
Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution
Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval, Site activation, Patient recruitment & retention
Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

RA Manager

Eitan Medical

Location:
Israel , Netanya

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 08, 2025

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