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

Principal Systems Integration Engineer - Rail

We are recruiting for a Systems Assurance and Systems Integration Principal Engi...

Location

United Kingdom , London; Birmingham; Manchester

Salary:

Not provided

Egis in the UK

Expiration Date

Until further notice

Requirements

Extensive experience in Engineering / Technical functions, with experience as a Assurance Manager / System Integrator
Excellent knowledge of railway infrastructure, systems, and operating requirements
Significant experience of integrating rail systems across multiple parties and contracts
Significant experience working on design and build contracts, within a design joint venture
Excellent understanding of rail engineering, including Metro, LRT, High Speed and Heavy Rail associated rail standards, and related regulations (TPG, CDM, CSM, RIR)
Excellent management skills with the ability to support, mentor and coordinate a team of engineers and technicians
Proven capability in managing design for a rail, especially in multi-disciplinary environments
Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers
Excellent engineering, analytical and problem-solving abilities
YOU MUST HAVE THE RIGHT TO WORK IN THE UK

Job Responsibility

Take a lead role in managing the design team in your discipline and managing all technical aspects related to interdisciplinary coordination
Implement efficient processes to manage system safety (including CDM, CSM-RA and interoperability), requirements management, Verification and Validation (V&V) and system assurance
Drive consistency of the deliverables across all projects
Contribute towards the standardisation of specifications and develop appropriate design criteria wherever not present
Liaise with the project team for all related issues or decisions, represent teams in meetings, provide technical opinion or support whenever needed
Contribute to the production of the project Requirements Specifications
Coordinate the Quality aspects of the sub-systems deliverables as per the project Quality Management plan principles
Review (wherever applicable) all deliverables, act as a technical control level across projects
Support the delivery teams

Systems Integration Engineer

We are recruiting for a Systems Assurance and Systems Integration Engineer to pr...

Location

United Kingdom , London; Birmingham; Manchester

Salary:

Not provided

Egis in the UK

Expiration Date

Until further notice

Requirements

Developing experience in Engineering / Technical functions, with experience or a willingness to develop limited experience as an Assurance Manager / System Integrator
Emerging knowledge of railway infrastructure, systems, and operating requirements
Developing experience of integrating rail systems across multiple parties and contracts
Foundational experience working on design and build contracts, within a design joint venture
Basic understanding of rail engineering, including Metro, LRT, High Speed and Heavy Rail associated rail standards, and related regulations (TPG, CDM, CSM, RIR)
Emerging capability in managing design for a rail, especially in multi-disciplinary environments
Excellent engineering, analytical and problem-solving abilities
BSc or similar in Bachelor Degree (BEng, BSc) in a Numerate, Scientific or Engineering subject or Higher Education/equivalent training and experience
YOU MUST HAVE THE RIGHT TO WORK IN THE UK

Job Responsibility

Take a supporting role to the Senior Engineer in managing the design team in your discipline and managing all technical aspects related to interdisciplinary coordination
Support the implementation of efficient processes to manage system safety (including CDM, CSM-RA and interoperability), requirements management, Verification and Validation (V&V) and system assurance
Support driving consistency of the deliverables across all projects
Contribute towards the standardisation of specifications
Liaise with the project team for all related issues or decisions
Contribute to the production of the project Requirements Specifications
Coordinate the Quality aspects of the sub-systems deliverables as per the project Quality Management plan principles
Support the delivery teams
Support the wider Egis team on future business development opportunities
This role may also include working on projects/bids internationally for Egis Transport Solutions or other Egis subsidiaries, including travel within the UK and Ireland

Senior Systems Integration Engineer - Rail

We are recruiting for a Systems Assurance and Systems Integration Senior Enginee...

Location

United Kingdom , London; Birmingham; Manchester

Salary:

Not provided

Egis in the UK

Expiration Date

Until further notice

Requirements

Proven experience in Engineering / Technical functions, with experience or a willingness to develop limited experience as an Assurance Manager / System Integrator
Good knowledge of railway infrastructure, systems, and operating requirements
Meaningful experience of integrating rail systems across multiple parties and contracts
Meaningful experience working on design and build contracts, within a design joint venture
Credible understanding of rail engineering, including Metro, LRT, High Speed and Heavy Rail associated rail standards, and related regulations (TPG, CDM, CSM, RIR)
Developed management skills with the ability to support, mentor and coordinate a team of engineers and technicians
Proven capability in managing design for a rail, especially in multi-disciplinary environments
Demonstrable relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers
Excellent engineering, analytical and problem-solving abilities
YOU MUST HAVE THE RIGHT TO WORK IN THE UK

Job Responsibility

Take a supporting role to the Principal Engineer in managing the design team in your discipline and managing all technical aspects related to interdisciplinary coordination
Support and where required lead the implementation of efficient processes to manage system safety (including CDM, CSM-RA and interoperability), requirements management, Verification and Validation (V&V) and system assurance
Support driving consistency of the deliverables across all projects
Contribute towards the standardisation of specifications and develop appropriate design criteria wherever not present
Liaise with the project team for all related issues or decisions and provide technical opinion or support whenever needed
Contribute to the production of the project Requirements Specifications
Coordinate the Quality aspects of the sub-systems deliverables as per the project Quality Management plan principles
Support the delivery teams

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Regulatory Affairs Intern

The RA Intern provides support for a variety of Regulatory Affairs activities re...

Location

United States , Tempe

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required, and currently enrolled in an undergraduate or graduate school program, or recent graduate
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Good problem solving and analytical skills
Good written and oral communication skills
Work across full suite of Microsoft office software programs, Adobe, and multiple internal software programs/databases

Job Responsibility

Provide general RA support for regulatory projects, under the direction of an RA professional
Effectively manage multiple competing priorities and work in a regulated environment
Assist with the collection of project related documentation and assist with preparation of regulatory submissions
Liaise with the subject matter experts to collect information and communicate with the team members
Assist in auditing, editing and publishing of regulatory submissions as appropriate

Regulatory Affairs Intern

The RA Intern provides support for a variety of Regulatory Affairs activities re...

Location

United States , Tempe

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Currently enrolled in an undergraduate or graduate school program, or recent graduate
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Good problem solving and analytical skills
Good written and oral communication skills
Ability to work in a regulated environment

Job Responsibility

Provide general RA support for regulatory projects, under the direction of an RA professional
Effectively manage multiple competing priorities
Assist with the collection of project related documentation and assist with preparation of regulatory submissions
Liaise with the subject matter experts to collect information and communicate with the team members
Assist in auditing, editing and publishing of regulatory submissions as appropriate
Work across full suite of Microsoft office software programs, Adobe, and multiple internal software programs/databases

Lead, Validation

The role of the Validation Lead is to conduct, coordinate and manage project rel...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Strong validation and install experience in relation to Facilities and Utilities in a Pharmaceutical, Medical Device or similar environment
Minimum: degree level education in Pharmacy, Chemistry, Microbiology, Engineering or similar or equivalent industry experience
Experience in Facilities and Utilities project validation to include HVAC, Cleanroom, Compressed Air etc.
Experience in 6-Sigma and Lean Manufacturing

Job Responsibility

Lead validation activities on specific projects including defining the validation requirements to ensure compliance and industrial guidance
Ability to translate local, corporate and regulatory requirements into validation requirements
Liaise with project team members
Change Control Management
Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and / or trial purposes
Run validation project execution IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved
Deviation / Non- Conformance management (including RA, RCA & CA/PA)
Proactively coordinate validation activities and act as a central point of contact for the project team for validation to ensure the projects are delivered on schedule
Author and report validation documentation to meet regulatory and Baxter standards
Resolve both GMP and business issues and deviations

What we offer

Pension
Annual Bonus
Health Insurance
Life Assurance
Work life Balance
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for RA Manager

Senior Regulatory Affairs Specialist

Principal Systems Integration Engineer - Rail

Systems Integration Engineer

Senior Systems Integration Engineer - Rail

Director, Regulatory Affairs – Americas & ANZ

Regulatory Affairs Intern

Regulatory Affairs Intern

Lead, Validation

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for RA Manager

Senior Regulatory Affairs Specialist

Principal Systems Integration Engineer - Rail

Systems Integration Engineer

Senior Systems Integration Engineer - Rail

Director, Regulatory Affairs – Americas & ANZ

Regulatory Affairs Intern

Regulatory Affairs Intern

Lead, Validation

Location:
Israel , Netanya

Category:
IT - Administration

Contract Type:
Not provided

Job Posted:
December 08, 2025