Ra Specialist Job at Product Life Group

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Job Responsibility

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Fulltime

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region
To ensure that RA processes are in place in his / her region

Job Responsibility

Local Complaint Coordinator activity
Product Surveillance activity for Medicinal Products and Medical Devices
Field Action execution
Supplier & Distributor Management
Implementation of Baxter Quality System in the region and audit management
NCR, CAPA and Change Management
Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available
To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO 9001 and 13485 requirements.

Senior Regulatory Affairs Product Specialist

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post-authorisation variations impacting CMC, Safety and Product Information
different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)
other RA activities such as renewals and PSURs/PSUSAs
CTD/eCTD documentation structure and lifecycle management
Knowledge and understanding of the following areas, European regulations and related guidance documents (e.g. management of documents, submissions, requirements): regulatory submissions across different markets and procedures, including the Centralised Procedure
Product Information authoring, editing and management
CMC documentation requirements
CTD and eCTD authoring, editing and lifecycle management
Able to perform other Regulatory Affairs activities with team support (e.g. PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries, including variations and lifecycle activities
Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders including MS&T, Quality, Pharmacovigilance, Supply and other teams
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO's and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

A fast-paced environment with broad exposure, giving you opportunities to develop professionally - even outside your core area of expertise
A culture that supports learning, celebrates success, and recognizes performance
Opportunities for driven and talented professionals to contribute to our exciting journey

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

Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota. ICON plc is a world-leading healthca...

Location

Colombia , Bogota

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in Pharmaceutical Chemist or next to graduate required
Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry
Knowledge or awareness of current regional guidelines and regulations is preferred
Technical knowledge in the preparation of a dossier is desirable
Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets
Advanced English level

Job Responsibility

Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries
Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises
Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool
Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations
Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area
Ensure that IP labels are in adherence to country requirements and submitted where applicable
Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor
Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team
Preparation of electronic regulatory submission of post-registration requests, HMPs, Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field at MoH
Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Regulatory Specialist II

Location

United States , Burnsville

Salary:

80000.00 - 110000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/ training
2-4 years’ regulatory related experience in a regulatory industry. Additional education may be substituted for years of experience
Demonstrated ability to communicate complex ideas clearly and simply both orally and in writing
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat
Must be able to work independently under limited supervision

Job Responsibility

Supports domestic and international strategies for regulatory approval of company products
Assists in coordination, compilation and submission of U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations
Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle
Completes technical and labeling reviews of supporting documents for inclusion in regulatory filings
Represents RA on other cross functional projects which may include process changes and continuous improvement efforts
Performs other related duties and responsibilities, as assigned

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

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

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

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Ra Specialist

Job Responsibility

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