Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Regulatory Affairs Specialist
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Support
Projektbeschreibung
REGULATORY AFFAIRS SPECIALIST - NORMAL
You are an expert in regulatory affairs who is specialised in the field of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
PROJECT DESCRIPTION:
Life cycle management RA support, for sterilization site change from external to internal
OVERALL RESPONSIBILITIES:
Support the internal Regulatory Affairs group in creation and maintenance of technical documentation
supporting compliance to
- European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,
- As well as country registrations on a world-wide basis, as appropriate.
POSITION DUTIES AND RESPONSIBILITIES:
- Ensuring that the company's products comply with the regulations set up by government
agencies - Advising engineering and manufacturing on regulatory requirements
- Assisting with reviewing of product and process documentation for assigned projects to ensure
compliance with change control requirements to aid in determining if regulatory submissions are
required
- Capturing and verification of regulatory product characteristics to support logistic and supply
chain efforts on a global scale
- Supporting team's daily operations of regulatory processes to ensure compliance with routine
regulatory reporting obligations
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals
REQUIREMENTS:
- Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
- 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Strong knowledge of
ISO 13485 and ISO 9001, QSR
Medical Devices applicable requirements, especially Council Directive 93/42/EEC and
Regulation 2017/745, as they pertain to technical documentation
MEDDEV guidance documents applicable to Medical Devices products and processes - Reasonable knowledge of FDA requirements registration requirements in further global markets would be an asset
- Strong understanding of Risk Management process, label and labeling, change management is
desired - Strong knowledge and skills in MS Office
- Familiarity with Technical Documentation structure according to STED required
- Team work oriented, within a multi-functional and multi-national team
- English spoken and written
- German would be a plus.
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
You are an expert in regulatory affairs who is specialised in the field of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
PROJECT DESCRIPTION:
Life cycle management RA support, for sterilization site change from external to internal
OVERALL RESPONSIBILITIES:
Support the internal Regulatory Affairs group in creation and maintenance of technical documentation
supporting compliance to
- European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,
- As well as country registrations on a world-wide basis, as appropriate.
POSITION DUTIES AND RESPONSIBILITIES:
- Ensuring that the company's products comply with the regulations set up by government
agencies - Advising engineering and manufacturing on regulatory requirements
- Assisting with reviewing of product and process documentation for assigned projects to ensure
compliance with change control requirements to aid in determining if regulatory submissions are
required
- Capturing and verification of regulatory product characteristics to support logistic and supply
chain efforts on a global scale
- Supporting team's daily operations of regulatory processes to ensure compliance with routine
regulatory reporting obligations
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals
REQUIREMENTS:
- Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
- 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Strong knowledge of
ISO 13485 and ISO 9001, QSR
Medical Devices applicable requirements, especially Council Directive 93/42/EEC and
Regulation 2017/745, as they pertain to technical documentation
MEDDEV guidance documents applicable to Medical Devices products and processes - Reasonable knowledge of FDA requirements registration requirements in further global markets would be an asset
- Strong understanding of Risk Management process, label and labeling, change management is
desired - Strong knowledge and skills in MS Office
- Familiarity with Technical Documentation structure according to STED required
- Team work oriented, within a multi-functional and multi-national team
- English spoken and written
- German would be a plus.
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges