Lavori attuali relativi a Regulatory Affairs Specialist - Salerno, Campania - Kerr
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Regulatory Affairs Specialist
2 mesi fa
Salerno, Italia Kerr A tempo pienoOperating Company: Kerr Location: Salerno,Campania,IT Date Posted: September 11, 2024 Req Number: R5020919 The Regulatory Affairs Specialist is responsible for establishing and sustaining CE Technical files, and final review of deliverables for MDR regulatory compliance. Furthermore, this position will be responsible for gathering and establishing...
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Regulatory Affairs Specialist
2 mesi fa
Salerno, Italia Kerr A tempo pienoOperating Company: Kerr Location: Salerno, Campania, IT Date Posted: September 11, 2024 Req Number: R5020919 Job Description: The Regulatory Affairs Specialist is responsible for establishing and sustaining CE Technical files, and final review of deliverables for MDR regulatory compliance.Furthermore, this position will be responsible for gathering and...
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Regulatory Affairs Specialist
3 settimane fa
Salerno, Italia Kerr A tempo pienoOperating Company: Kerr Location: Salerno, Campania, IT Date Posted: September 11, 2024 Req Number: R5020919 Job Description: The Regulatory Affairs Specialist is responsible for establishing and sustaining CE Technical files, and final review of deliverables for MDR regulatory compliance. Furthermore, this position will be responsible for gathering and...
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Regulatory Affairs Specialist
4 settimane fa
Salerno, Italia Kerr A tempo pienoOperating Company: KerrLocation: Salerno, Campania, ITDate Posted: September 11, 2024Req Number: R5020919Job Description:The Regulatory Affairs Specialist is responsible for establishing and sustaining CE Technical files, and final review of deliverables for MDR regulatory compliance. Furthermore, this position will be responsible for gathering and...
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Regulatory & Legal
1 mese fa
Salerno, Italia Stantup A tempo pienoSempre alla ricerca di talenti da unire al nostro team.Siamo costantemente alla ricerca di nuovi talenti che condividano la nostra passione per l'innovazione e la collaborazione.Se ritieni di poter contribuire al nostro team con le tue competenze e la tua determinazione, inviaci la tua candidatura.Crescita Esponenziale e progetti ambiziosi.Con il nostro...
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Regulatory & Legal
1 mese fa
Salerno, Italia Stantup A tempo pienoSempre alla ricerca di talenti da unire al nostro team.Siamo costantemente alla ricerca di nuovi talenti che condividano la nostra passione per l'innovazione e la collaborazione. Se ritieni di poter contribuire al nostro team con le tue competenze e la tua determinazione, inviaci la tua candidatura.Crescita Esponenziale e progetti ambiziosi.Con il nostro...
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Regulatory & Legal
1 mese fa
Salerno, Italia Stantup A tempo pienoSempre alla ricerca di talenti da unire al nostro team. Siamo costantemente alla ricerca di nuovi talenti che condividano la nostra passione per l'innovazione e la collaborazione. Se ritieni di poter contribuire al nostro team con le tue competenze e la tua determinazione, inviaci la tua candidatura.Crescita Esponenziale e progetti ambiziosi. Con il nostro...
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Regulatory & Legal
3 settimane fa
Salerno, Italia Stantup A tempo pienoSempre alla ricerca di talenti da unire al nostro team. Siamo costantemente alla ricerca di nuovi talenti che condividano la nostra passione per l’innovazione e la collaborazione. Se ritieni di poter contribuire al nostro team con le tue competenze e la tua determinazione, inviaci la tua candidatura. Crescita Esponenziale e progetti ambiziosi. Con il...
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Regulatory & Legal
8 ore fa
Salerno, Italia Stantup A tempo pienoSempre alla ricerca di talenti da unire al nostro team.Siamo costantemente alla ricerca di nuovi talenti che condividano la nostra passione per l’innovazione e la collaborazione. Se ritieni di poter contribuire al nostro team con le tue competenze e la tua determinazione, inviaci la tua candidatura.Crescita Esponenziale e progetti ambiziosi.Con il nostro...
Regulatory Affairs Specialist
2 mesi fa
About the Role:
Kerr is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring the company's medical devices comply with EU MDR regulations.
Key Responsibilities:
- Establish and maintain CE Technical files for medical devices.
- Review and approve deliverables for MDR regulatory compliance.
- Gather and establish documentation for international registrations and licenses.
- Provide Regulatory Affairs support for project remediation projects and global product registrations.
- Develop and execute regulatory strategies for sustaining and new products.
- Review and approve change orders for compliance with FDA, European and/or global regulations and standards.
- Create action plans to ensure milestones and due dates are met.
- Support CAPA projects and review Nonconformance Reports for regulatory impact.
- Review and redline product labels/IFUs to meet global regulatory requirements.
- Ensure label conformity to global UDI requirements and submit/maintain UDI databases.
- Initiate and update regulatory requirements as required and per applicable SOPs.
- Participate in audits and inspections of the company and its Quality Systems.
- Prepare monthly reports on status of current issues to the Manager of Regulatory Affairs.
- Resolve regulatory issues and ensure companywide compliance.
Requirements:
- Bachelor's degree from a university in engineering or a scientific/technical field or Regulatory Affairs.
- English language proficiency.
- 2+ years of experience in a Regulatory Affairs role within the Medical Device or Pharmaceutical industry.
- Ability to understand technical product information.
- Effective collaborator with department and cross-functional team members.
- Demonstrated organizational problem-solving skills, project coordination skills, and computer literacy in Microsoft Office suite, databases, and electronic document management systems.
- Enthusiastic self-starter with excellent verbal, written, and interpersonal skills.
- Highly organized, detail-oriented mindset, and ability to be flexible and multi-task in a dynamically changing environment.
- Ability to interpret and provide guidance on regulations from various countries.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
