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

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

New

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

Assistant Manager Product Sales RA

Manage product and range feedback based on customer insights, working closely wi...

Location

China , Shanghai

Salary:

Not provided

Adidas

Expiration Date

Until further notice

Requirements

University degree in Business, or equivalent professional experience, ideally with Sales / buying / merchandising experience
5 years+ of broad merchandising experience
ideally with both category merchandising and retail merchandising experience
Or 5 years+ of account management experience
ideally with key account management
Strong interpersonal and relationship management skills
Excellent communications, influencing and negotiating abilities, strong presentation skills
High degree of commercial and business acumen knowledge (e.g. sales, trade marketing, finance and controlling)
Strong analytical skills, strong commercial and business / product acumen knowledge
Fluent in written and spoken local language as well as English

Job Responsibility

Communicate with customer, to land buying strategy and guidance to achieve OTB target
Follow GTM process sign-off and manage customer OTB tracking
Collect and filter product feedback from customer and feedback to FRS buying (Regular feedback / SMM / MW / Assortment / In-season feedback, etc.) as the role of key product interface with customers
OTB landing execution to customer include buying structure, product ranges and packages (Order information communication / collection / adjustment landing / Mandatory order execution, Store list collection and maintenance etc.)
Ensure product landing in store through collaborating with Retail Ops team at in-season trading
Provide product performance review and analysis on account level, and provide insights to support sales leader to fully understand sales from product perspective
Provide analysis on products ranges / buying plan and inputs on buying plan specific to customer and stores level which fits customer business
Product promotion and incentive by branch level tracking to drive product ST and inventory control to align with sales strategy
Work with Sales Operations regarding order delay and order cancel maintenance
Key business meeting arrangement and logistics (COVA / SMM / TM, etc.) and Trade Meeting Highlight room walk-through with customers

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

Civil Engineer – Construction

Deliver end-to-end site execution for civil and structural works, ensure green b...

Location

India , Hyderabad

Salary:

Not provided

Unilever

Expiration Date

Until further notice

Requirements

B.E./B.Tech in Civil Engineering
5–10 years in industrial/commercial construction
at least one project involving water/wastewater treatment
at least one green building–certified or targeted project (IGBC/LEED/GRIHA)
Working knowledge of IS codes, NBC 2016, IS 456, IS 800, IS 875, IS 3370 (liquid retaining), welding/NDT basics, relevant environmental and wastewater guidelines
Proficiency in AutoCAD, MS Project/Primavera, MS Excel, BIM (Navisworks/Revit preferred), QA/QC digital tools, surveying (Total Station) basics
Strong site execution leadership and contractor management
Reading/interpreting drawings, BBS, and shop drawings
Concrete technology, waterproofing systems, and structural steel erection know-how
Understanding of wastewater process layouts, levels, watertight structures, and corrosion protection

Job Responsibility

Deliver end-to-end site execution for civil and structural works, ensure green building compliance, and support water/wastewater treatment infrastructure construction—meeting safety, quality, cost, and schedule targets
Supervise execution of earthworks, foundations, PCC/RCC/structural steel, masonry, flooring, waterproofing, paving, and drains as per approved drawings and method statements
Review IFC drawings, manage RFIs, deviations, and redlines
coordinate with design/PMC for constructability and field changes
Ensure compliance with applicable codes and client specifications
Conduct bar bending schedule (BBS) checks, rebar inspections, shuttering/formwork checks, concrete pour approvals, slump and cube tests
Complete Ground level planning in PEB errections schedules and Monitor the quality of executions
Monitor structural steel fabrication/erection (fit-up, welding, bolting, NDT, alignment)
Interface planning with MEP/utilities to avoid clashes
coordinate underground services and civil inserts/sleeves

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

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

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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Job Description:

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