International Regulatory Affairs Associate/senior
Il y a 2 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 multi-functional 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 follow-up of corrective / preventive actions if necessary
- Provide input to risk management plans and risk management files in line with ISO14971
- 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 multi-functional 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 follow-up of corrective / preventive actions if necessary
- Provide input to risk management plans and risk management files in line with ISO14971
- 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
- 2-4 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
- Self-motivated, 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
-
International Regulatory Affairs Associate/senior
il y a 1 semaine
Nazareth, Flandre, 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 an International Regulatory Affairs Associate/Senior Associate dependent on experience to be based in our Nazareth, Belgium...
-
International Regulatory Affairs Senior Associate
Il y a 2 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...
-
International Regulatory Affairs Senior Associate
il y a 1 semaine
Nazareth, Flandre, 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 Nazareth...
-
Regulatory Affairs Senior Associate
il y a 1 semaine
Nazareth, Flandre, 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, ParisIn this role you will work on Regulatory Affairs projects as required to meet business needsIt...
-
Regulatory Affairs Senior Associate
il y a 2 semaines
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 2 semaines
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...
-
Professional Regulatory Affairs
il y a 4 semaines
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 Belgium is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. Regulatory...
-
Professional Regulatory Affairs
il y a 2 jours
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 Belgium is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. Regulatory...
-
Professional Regulatory Affairs
il y a 10 heures
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 Belgium is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. Regulatory...
-
Regulatory Affairs Project Manager
il y a 1 semaine
Nazareth, Flandre, 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 seeking a dedicated REGULATORY AFFAIRS PROJECT MANAGER - ORAL CARE to join our central RA team based out of Nazareth, Belgium.This...
-
Quality Assurance Associate/senior Quality
Il y a 2 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 a dedicated **Quality Assurance Associate/ Senior Associate** to join our Central QA team based in our **Nazareth,...
-
Regulatory Affairs Project Manager
Il y a 2 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 seeking a dedicated REGULATORY AFFAIRS PROJECT MANAGER - ORAL CARE to join our central RA team based out of Nazareth,...
-
Ra Senior Associate
il y a 4 semaines
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...
-
Ra Senior Associate
il y a 10 heures
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...
-
Quality Assurance Associate/senior Quality
il y a 1 semaine
Nazareth, Flandre, 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 a dedicated Quality Assurance Associate/ Senior Associate to join our Central QA team based in our Nazareth, Belgium...
-
QA Csv Systems Associate
il y a 4 semaines
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...
-
QA Csv Systems Associate
il y a 4 semaines
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...
-
QA Csv Systems Associate
il y a 1 jour
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 2 semaines
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,...
-
QA Csv Systems Associate
il y a 1 semaine
Nazareth, Flandre, 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 former...
