Emplois actuels liés à International Regulatory Affairs Associate/senior - Nazareth, Flandre - Perrigo
-
International Regulatory Affairs Senior Associate
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Thank you for being part of our mission. **Description Overview**: We are excited to be recruiting for an International Regulatory Affairs Senior Associate to be based in either our London, Paris, Rotterdam, or...
-
Regulatory Affairs Senior Associate
Il y a 4 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: This role can be based in any of the following locations: Ghent, London, Paris In this role you will work on Regulatory Affairs projects as required to meet business...
-
Regulatory Affairs Senior Associate
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: 7 Month Fixed Term Contract This role can be based in any of the following locations: Ghent, London, Paris In this role you will work on Regulatory Affairs projects...
-
Ra Senior Associate
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: To work on Regulatory Affairs projects as required to meet business needs To ensure compliance with Cosmetic Regulation 1223/2009/EC & other regulatory requirements To...
-
QA Csv Systems Associate
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the...
-
Lead Coordinator Artwork
Il y a 4 mois
Nazareth, Belgique Perrigo Temps plein**Description Overview**: Currently we are looking for a new team member**: "Lead Coordinator Artwork"** for our office Nazareth (full time and permanent contract). In this amazing role you will coordinate the packaging artwork changes and launches for the Perrigo CSCI (Consumer Self-Care International) top-20 brands including XLS, Dermalex, Coldrex,...
-
Artwork Coordinator Assistant
Il y a 3 mois
Nazareth, Belgique Perrigo Temps plein**Description Overview**: We have an exciting opportunity for an** Artwork Coordinator** to join the team on a 2 year fixed term contract working part time 20h/week. In this role you will be responsible for coordinating the packaging artwork changes/launches for the Perrigo CSCI (Consumer Self-Care International) top-20 brands including XLS, Dermalex,...
-
Quality Assurance Associate
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: You will act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Corporate & Country QA group. **Scope of the Role**: - Ensure...
-
Quality Assurance Associate
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: You will join our Quality Assurance team and contribute to the QA vision, strategy and standards for the integrated Corporate & Country QA group. You will have the...
-
Senior Designer
il y a 3 semaines
Nazareth, Belgique Move Jobs Temps pleinLocatie **Nazareth** Sector Marketing & communication **SENIOR DESIGNER**: Voor onze klant, een standen -en interieurbouwbedrijf, ga ik op zoek naar een SENIOR designer, dit ter versterking van het team. Taken: - Je bent verantwoordelijk voor het ontwerpen en uittekenen van hoofdzakelijk beursstanden, dit voor verschillende internationale...
-
Senior SAP Financial Systems Analyst
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: - The Senior Financial Systems Analyst is responsible for overseeing the processes and procedure to ensure data integrity of Finance systems and continually assessing...
-
International Payroll Manager
Il y a 3 mois
Nazareth, Belgique Perrigo Temps plein**Description Overview**: Perrigo have an exciting opportunity for an experienced Payroll professional to join the Europe team. It's a truly dynamic and diverse environment, working with an amazing team of like-minded professionals to provide an exceptional service to our employee population/stakeholders primarily in Belgium, Netherlands, Germany & Austria....
-
Project and Portfolio Manager
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Thank you for being part of our mission. **Description Overview**: We are currently recruiting for a Portfolio and Project Management, Lead Project Manager to join our OTC business unit team. The role can be based in...
-
Senior Account Manager
Il y a 3 mois
Nazareth, Belgique Perrigo Temps plein**Description Overview**: Perrigo Belgium is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. The function of Lead Medical & Hospital is part of the Sales department and is responsible to develop the Perrigo brands in the following sectors: Hospitals, Service Flats, Rest and...
-
Accountant
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: Currently seeing a General accountant who will perform a variety of accounting activities in accordance with accounting principles and standards to control the...
-
Senior SAP Financial Systems Analyst
Il y a 3 mois
Nazareth, Belgique Perrigo Temps plein**Description Overview**: - The Senior Financial Systems Analyst is responsible for overseeing the processes and procedure to ensure data integrity of Finance systems and continually assessing for optimization to drive efficiencies and institutional effectiveness. - They will work with functional Finance leaders to confirm, control effectiveness, and pursue...
-
Project Manager
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: We are excited to be recruiting for a Project Manager to join our OTC - Core OTC, Wellness & Lifestyle group, which develops brand portfolios in Smoking Cessation,...
-
Innovation Manager
Il y a 4 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: We are excited to be recruiting for a dedicated Product developer Nutraceuticals to join our Nutraceuticals Category Team. This position will suit an R&D professional...
-
Sales Development Manager Integrated Systems
Il y a 4 mois
Nazareth, Belgique Hach Temps pleinAre you - Interested in growing your career in a commercial-technical development role? - Looking to use your creativity and skills to offer advanced solutions to our customers? - Interested in working in a dynamic, driven and personable team in an international environment? If so, read on! At Hach, we ensure water quality for people around the world....
-
Senior Quality Specialist
Il y a 3 mois
Nazareth, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. **Description Overview**: Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the...
International Regulatory Affairs Associate/senior
Il y a 3 mois
Perrigo is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.
Thank you for being part of our mission.Description Overview:
We are excited to be recruiting an International Regulatory Affairs Associate/Senior Associate dependent on experience to be based in our Nazareth, Belgium location.
At Associate level, we are happy to consider graduates and individuals at the cusp of their RA careerThe main responsibilities of the role will be to work on Regulatory Affairs projects as required to meet business needs and ensure Regulatory Compliance of the company's products with all relevant legislation around Medical Devices, including ISO13485, ISO14971 and other harmonized standards, IVD and MD directives, MDR & other regulatory requirements.
Scope of the Role:
- Work as part of a multifunctional team by providing regulatory input to new product development, including artwork approvals, label claims and associated supporting documentation. Contribute toward strategy, preparation and submission of new regulatory filings
- Depending on experience, represent the regulatory department in one or more product categories as primary point of contact and provide input to management.
- Support and drive the process of CE marking of new and existing products.
- Discuss strategy and issues internally and with authorities/third parties as needed.
- Analyse regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and support with regulatory intelligence
- As part of the team ensure product registrations are correct and compliant with the relevant legislation.
- Provide support in maintaining the ISO13485 Quality Management System
- Assist in the process of reporting and investigating critical nonconformities and opportunities for improvement
- Support on report and followup of corrective / preventive actions if necessary
- Provide input to risk management plans and risk management files in line with ISO1497
- Provide input for analysis of data and/or management review, if required
- Carry out other related regulatory affairs duties as requiredWork as part of a multifunctional team by providing regulatory input to new product development, including artwork approvals, label claims and associated supporting documentation. Contribute toward strategy, preparation and submission of new regulatory filings
- Depending on experience, represent the regulatory department in one or more product categories as primary point of contact and provide input to management.
- Support and drive the process of CE marking of new and existing products.
- Discuss strategy and issues internally and with authorities/third parties as needed.
- Analyse regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and support with regulatory intelligence
- As part of the team ensure product registrations are correct and compliant with the relevant legislation.
- Maintain, review, approve and update of technical files compliance with the MDD 93/42/EEC and IVD 98/79/EC
- Approve Master Artwork and Master Texts from a regulatory perspective
- Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory
- Initiate corrections to Master Documents & Regulatory Affairs Procedures as required
- Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes
- Provide support in maintaining the ISO13485 Quality Management System
- Assist in the process of reporting and investigating critical nonconformities and opportunities for improvement
- Support on report and followup of corrective / preventive actions if necessary
- Provide input to risk management plans and risk management files in line with ISO1497
- Provide input for analysis of data and/or management review, if required
- Carry out other related regulatory affairs duties as required
Experience Required:
- Bachelor or Master's degree in Medical/Life Sciences or other relevant fields
- 24 years of experience in a regulatory environment is desired for the Senior Associate role, but we are happy to consider graduates with the right motivation for the Associate level
- Selfmotivated, flexible and open to changing requirements
- Highly driven with enthusiasm to meet requirements and cope under demanding pressure
- The ability to work autonomously and in team
- The ability to lead and support several concurrent projects/products
- The ability to priorities decisions and activities to ensure efficient use of resources and address critical issues impacting the business
- Excellent project management and administrative skills
- Passion for products and regulatory compliance management
- Being thorough and focused
