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Global (Senior) Regulatory Affairs Manager - Medical Devices

Employer
i-Pharm Consulting
Location
Australia, Melbourne, Victoria / Sydney, Australia, New South Wales
Salary
Negotiable
Start date
17 Oct 2019
Closing date
16 Nov 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

JOB TITLE

Senior Regulatory Affairs Manager - Medical Devices - Melbourne Based

JOB SUMMARY

The management team invested in this company is top tier.

They are looking for someone who will work at the Global HQ and enable the organisation to branch out into other countries of the world. R & D and Manufacturing is largely based on shore.

This role will have a large part to play in that outcome and essentially grow this highly successful company to the next phase of their growth.

This position will pave the way for true ambition to be fulfilled. The company is in a strong position and well funded, therefore will suit an achiever who wishes to make an impact. This influence will not just help corporate deliverables to be met, but also provide more deserving patients around the world the access they need to the company's innovative medical technology.

The role ultimately reports into the US Head of Regulatory Affairs however there is a strong need to appoint someone with a strategic mind and passionate line manager for global operations.

Someone who will relish in continuous company growth and like a fast paced environment in the truest sense. A genuinely exciting time for this health technology research, patients and company alike.

ROLE/DESCRIPTION

  • full line management of a small global (largely localised currently) team
  • driving the execution of global submissions
  • TGA, Medsafe, ROW, US FDA
  • Identify regulatory opportunities that facilitate commercial market entry
  • Manage the document control function
  • QMS Matrix training
  • Product approval
  • working closely with Marketing, R & D and post market surveillance
  • full exposure to working on market commercial entry
  • work closely with scientists / engineers
  • maintain regulatory registrations
  • working through product recalls
  • Regulatory liaison for international matters relating to product file compliance / labelling

REQUIREMENTS

  • Life sciences degree (pharmacy preferred)
  • Experience with TGA & Medsafe
  • Global product submissions experience
  • Worked previously supporting manufacturing and R & D previously
  • TGA, Medsafe, ROW, US FDA
  • ISO 9001 / 13485 knowledge
  • Line management is a pre requisite
  • Electronic QMS in a medical device setting (ISO 13485)

REQUIREMENTS

  • Life sciences degree (pharmacy preferred)
  • Experience with TGA & Medsafe
  • Global product submissions experience
  • Worked previously supporting manufacturing and R & D previously
  • TGA, Medsafe, ROW, US FDA
  • ISO 9001 / 13485 knowledge
  • Line management is a pre requisite
  • Electronic QMS in a medical device setting (ISO 13485)

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.com. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

Quality Engineer, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 13485.

Principal Consultant, Senior RA Associate, Senior Regulatory Affairs Associate, Regulatory Affairs Associate, Regulatory Affairs Manager, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, Regulatory Training, Regulatory Trainer, Renewals.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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