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Regulatory Affairs Manager

Keywords / Skills : Regulatory Affairs Manager

Posted: 2019-03-05

Regulatory Affairs Manager
Posted On
5th Mar 2019
Job Ref code
Job Description
Job Description :

Job Description

Regulatory Affairs Specialist/Manager (Country Manager)

General description of position/area of responsibility:
  • Provide the Regulatory Affairs department with country specific regulatory input supporting product development and product lifecycle management
  • Ensure regulatory approval and maintenance of products (active devices and software as a medical device) and in collaboration with regulatory consultants, if relevant
  • Review product and packaging labels, IFUs, marketing material
  • Answer questions from Competent Authorities concerning regulatory topics in collaboration with Regulatory Affairs department and/or regulatory consultants, if relevant.
  • Responsible for communication with Competent Authorities with regard to vigilance cases, recalls and FSNs in collaboration Regulatory Affairs department and/or regulatory consultant, if relevant.
  • Communication with customers regarding regulatory issues.
  • Ensure that the company's policies, procedures and operating guidelines conform to country specific laws, regulations and industry practices.
  • Responsible for the daily collaboration with regulatory consultants as well as evaluation of performance and costs.
  • If decided, establish and maintain procedures required for local entity to act as Marketing authorization holder
  • Act as qualified person for local office, if required by Competent Authority.
  • Act as QMS Management Representative, if required by Competent Authority.
  • Act as local responsible person for post-market surveillance activities, if required by Competent Authority.

Relevant technical, engineering or natural science background, preferably a university degree.

Competences needed: (professional/personal)
  • Experience with regulatory affairs from a medical device company, preferably with active devices and/or software devices.
  • Familiar with country specific Medical Device regulation (PMDA, KFDA, ANVISA, CFDA) as well as ISO13485, ISO 62304, Low Voltage Directive and EMC Directive etc.
  • Excellent planning, cooperation, and communication skills.
  • Fluent in English with excellent verbal and written communication skills.

Expected primary results/

Success criteria:

Measured by/ more detailed description:

Regulatory support
Provide Regulatory Affairs department with country specific regulatory input

Regulatory approvals
Acquire relevant national approvals to support sales

Regulatory support
Support to local sales offices with regard to regulatory issues

Tasks (prioritized):

Detailed description:

% of time (if relevant):

Ensure that the company acquires the relevant local approvals.


Maintenance of products on the market according to regulations

Qualified and interested Parties please apply with your CV and latest salary in Word format to
Please note, that while Morgan Philips welcomes and appreciates all candidate response, volume of replies allows us to respond to short-listed candidates only. Resumes are collected for recruitment purposes only.

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