for a Regulatory Affairs Specialist to join their team.
This is an excellent opportunity to experience an International
Regulatory Affairs role with a leading medical devices Corporation, to
build upon your professional knowledge of global market clearance
procedures as well as of active (electro-medical) and disposable
standards compliance.
Purpose of Role
The function of Regulatory Affairs Specialist is to combine knowledge
of scientific, regulatory and business issues to enable products that
are developed, manufactured and distributed to meet applicable
regulatory requirements and applicable technical standards.
The individual has to gain department and platform influence by
co-operating in all RA accomplishments and sharing regulatory
knowledge of demonstrating compliance with changing global
regulations, also identifying, preparing and collecting data needed to
obtain and maintain certifications and commercialization
authorizations of BD products.
Essential Duties and Responsibilities
Lead and execute OUS international product registrations attending to
individual country specific requirements; monitor and report progress
Prepare and maintain regulatory files such as STED and MDD/MDR
Technical Files;
Participation in cross-functional product development teams as the
regulatory representative; development of regulatory strategies
Engages in approval processes and monitor the relevant timelines;
Attends to the Corporate information network, monitoring International
regulatory developments to identify and communicate applicable
requirements;
Assesses changes in regulations and helps to determine their impact;
Participate to the review of process/product changes, labeling,
claims, product complaints, A&Ps (Advertising & Promotional
materials), etc., to determine the need for any regulatory activities
and to ensure compliance to International requirements;
Attends to audits performed by internal and external authorities to
represent RA positions and processes;
Prepare regulatory dossiers for submission to Health Authorities and
maintains them along the whole product life-cycle.
Required education and training
BSC in Electronics or Biomedical engineering discipline, or equivalent
proven experience.
Essential skills and knowledge
Sound knowledge of the regulatory framework pertaining to Medical
Devices such as the MDD CE Marking;
Experience in International Standards in particular: ISO **Apply on
the website**, ISO **Apply on the website** and IEC **Apply on the
website** series;
Good working knowledge of Design Control, Software Life Cycle, Risk
Mngt, V&V (e.g. BioCompatibility) processes;
Experience
Proven regulatory affairs experience within the medical technology
industry or equivalent;
Demonstrated compliance experience with all MDD classes medical
devices, possibly including (P)EMS - (Programmable) Electrical Medical
Systems;
Demonstrated experience working in cGXP environments and in new
Product Development projects;
Solid knowledge and material experience in International
registrations/approval process for medical devices.
Orion Electrotech Ltd acts as both an Employment Business and
Employment Agency and complies with the Conduct of Employment Agencies
and Employment Businesses Regulations Act **Apply on the website**.
By applying for this position please take a few moments to view our
Privacy Notice on our Orion website which details how we retain and
process your data. Alternatively please give us a call so we can
discuss this with you My client, a leading medical device company, are currently recruiting
for a Regulatory Affairs Specialist to join their team.
This is an excellent opportunity to experience an International
Regulatory Affairs role with a leading medical devices Corporation, to
build upon your professional knowledge of global market clearance
procedures as well as of active (electro-medical) and disposable
standards compliance.
Purpose of Role
The function of Regulatory Affairs Specialist is to combine knowledge
of scientific, regulatory and business issues to enable products that
are developed, manufactured and distributed to meet applicable
regulatory requirements and applicable technical standards.
The individual has to gain department and platform influence by
co-operating in all RA accomplishments and sharing regulatory
knowledge of demonstrating compliance with changing global
regulations, also identifying, preparing and collecting data needed to
obtain and maintain certifications and commercialization
authorizations of BD products.
Essential Duties and Responsibilities
Lead and execute OUS international product registrations attending to
individual country specific requirements; monitor and report progress
Prepare and maintain regulatory files such as STED and MDD/MDR
Technical Files;
Participation in cross-functional product development teams as the
regulatory representative; development of regulatory strategies
Engages in approval processes and monitor the relevant timelines;
Attends to the Corporate information network, monitoring International
regulatory developments to identify and communicate applicable
requirements;
Assesses changes in regulations and helps to determine their impact;
Participate to the review of process/product changes, labeling,
claims, product complaints, A&Ps (Advertising & Promotional
materials), etc., to determine the need for any regulatory activities
and to ensure compliance to International requirements;
Attends to audits performed by internal and external authorities to
represent RA positions and processes;
Prepare regulatory dossiers for submission to Health Authorities and
maintains them along the whole product life-cycle.
Required education and training
BSC in Electronics or Biomedical engineering discipline, or equivalent
proven experience.
Essential skills and knowledge
Sound knowledge of the regulatory framework pertaining to Medical
Devices such as the MDD CE Marking;
Experience in International Standards in particular: ISO **Apply on
the website**, ISO **Apply on the website** and IEC **Apply on the
website** series;
Good working knowledge of Design Control, Software Life Cycle, Risk
Mngt, V&V (e.g. BioCompatibility) processes;
Experience
Proven regulatory affairs experience within the medical technology
industry or equivalent;
Demonstrated compliance experience with all MDD classes medical
devices, possibly including (P)EMS - (Programmable) Electrical Medical
Systems;
Demonstrated experience working in cGXP environments and in new
Product Development projects;
Solid knowledge and material experience in International
registrations/approval process for medical devices.
Orion Electrotech Ltd acts as both an Employment Business and
Employment Agency and complies with the Conduct of Employment Agencies
and Employment Businesses Regulations Act **Apply on the website**.
By applying for this position please take a few moments to view our
Privacy Notice on our Orion website which details how we retain and
process your data. Alternatively please give us a call so we can
discuss this with you
We need : English (Good)
Type: Permanent
Payment:
Category: Others
