Work From HomeWe are actively seeking to recruit a Regulatory
Communications Specialist to serve as a communication liaison between
the manufacturer and the local affiliates or regulatory authorities of
a leading Medical Device multinational. The successful candidate will
assist in assessing complaints for Regulatory Reporting, this includes
Adverse Event Reporting (MDR, Vigilance, etc.), Post Market
Surveillance Activities (PMS), field action and associated
correspondence to applicable Regulatory
_RESPONSIBILITIES_ ??
* Assess complaints from global customer support and delivery centres
for adequate information to determine if event meets Regulatory
Reporting requirements. ?
* Utilize appropriate complaint software systems for processing
complaints to/from customer support and delivery centres and QE
Investigation functions. ?
* Generate appropriate regulatory reports based on assessment. ?
* Liaise effectively with regulators on all issues with regard to
regulatory reporting. ?
* Ensuring that confirmed reportable events are escalated to the
appropriate personnel in a timely manner. ?
* Communicate with other Companies globally as necessary for
reporting. ?
* Generate responses to inquiries on AE reports from various global
regulatory authorities. ?
* Generate various reports, including but not limited to, Regulatory
requests, Marketing requests, Engineering requests. ?
* Input into the assessment of field action through the Health Risk
Assessment process. ?
* Close out of complaints as necessary. ?
* Input and adherence to the scheduling and management of Post Market
Surveillance (PMS) plans and reports. ?
* Responsibility for implementing applicable regulatory requirements
in accordance with ISO
**Apply on the website**, MDD **Apply on the website**/**Apply on the
website**/EEC, EU Medical Device Regulation **Apply on the
website**/**Apply on the website** and FDA QSP **Apply on the
website**
CFR Part **Apply on the website** as required. ?
* Maintains and organises appropriate regulatory records to
demonstrate compliance with applicable regulations.
_QUALIFICATIONS_ /
REQUIREMENTS:
* Third level Qualification in Science/Engineering desired. ?
* A number of years experience in a regulated industry in a similar
role required. ?
* Thorough knowledge of the EU & US medical device regulatory
requirements. ?
* Knowledge of regulatory requirements in MDSAP countries. ?
* Desirable to have knowledge of requirements in other jurisdictions.
?
* Knowledge of medical device quality standards/practises or similar
regulated industry. ?
* Good communication and inter-personal skills. ?
* Proven problem-solving skills. ?
* Good computer skills including knowledge of Microsoft? Office. ?
* Proven organisational skills. ?
* High self-motivation. ?
* Willingness and availability to travel on company business.
For more information and a full job spec contact Nicola on (phone
number removed) or email your CV in the strictest confidence to Regulatory Communications Specialist
Work From HomeWe are actively seeking to recruit a Regulatory
Communications Specialist to serve as a communication liaison between
the manufacturer and the local affiliates or regulatory authorities of
a leading Medical Device multinational. The successful candidate will
assist in assessing complaints for Regulatory Reporting, this includes
Adverse Event Reporting (MDR, Vigilance, etc.), Post Market
Surveillance Activities (PMS), field action and associated
correspondence to applicable Regulatory
_RESPONSIBILITIES_ ??
* Assess complaints from global customer support and delivery centres
for adequate information to determine if event meets Regulatory
Reporting requirements. ?
* Utilize appropriate complaint software systems for processing
complaints to/from customer support and delivery centres and QE
Investigation functions. ?
* Generate appropriate regulatory reports based on assessment. ?
* Liaise effectively with regulators on all issues with regard to
regulatory reporting. ?
* Ensuring that confirmed reportable events are escalated to the
appropriate personnel in a timely manner. ?
* Communicate with other Companies globally as necessary for
reporting. ?
* Generate responses to inquiries on AE reports from various global
regulatory authorities. ?
* Generate various reports, including but not limited to, Regulatory
requests, Marketing requests, Engineering requests. ?
* Input into the assessment of field action through the Health Risk
Assessment process. ?
* Close out of complaints as necessary. ?
* Input and adherence to the scheduling and management of Post Market
Surveillance (PMS) plans and reports. ?
* Responsibility for implementing applicable regulatory requirements
in accordance with ISO
**Apply on the website**, MDD **Apply on the website**/**Apply on the
website**/EEC, EU Medical Device Regulation **Apply on the
website**/**Apply on the website** and FDA QSP **Apply on the
website**
CFR Part **Apply on the website** as required. ?
* Maintains and organises appropriate regulatory records to
demonstrate compliance with applicable regulations.
_QUALIFICATIONS_ /
REQUIREMENTS:
* Third level Qualification in Science/Engineering desired. ?
* A number of years experience in a regulated industry in a similar
role required. ?
* Thorough knowledge of the EU & US medical device regulatory
requirements. ?
* Knowledge of regulatory requirements in MDSAP countries. ?
* Desirable to have knowledge of requirements in other jurisdictions.
?
* Knowledge of medical device quality standards/practises or similar
regulated industry. ?
* Good communication and inter-personal skills. ?
* Proven problem-solving skills. ?
* Good computer skills including knowledge of Microsoft? Office. ?
* Proven organisational skills. ?
* High self-motivation. ?
* Willingness and availability to travel on company business.
For more information and a full job spec contact Nicola on (phone
number removed) or email your CV in the strictest confidence to
We need : English (Good)
Type: Permanent
Payment:
Category: Others
