Regulatory And Clinical Manager

Hiring By - Biostaffic

 BioPharma

Australia

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details
  • Highly successful Innovative medical diagnostics R&D Manufacturer is recruiting a Regulatory and Clinical Manager to manage Regulatory operations.

    This role is standalone currently with a view to down the line perhaps managing people.

    The management team invested in this company is top tier with great momentum opening up pathways in a number of regions already.

    They are looking for someone who will work at the Global HQ in Melbourne and enable the organisation to branch out into other countries of the world.

    Reporting into the CTO.

    The company is in a strong position and well funded, therefore will suit an achiever who wishes to make an impact and like fast pace.

    This covering 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.

    This role will be supporting by external consultants global however is a global remit.

    Someone who will relish in continuous company growth and like a fast paced environment in the truest sense. This company is well established with HR processes and training programs.

    A genuinely exciting time for this health technology research, patients and company alike.

    ROLE/DESCRIPTION

    • full line management of small team
    • driving the execution of local submissions
    • MDD/MDR Conformity Assessment
    • IVDR
    • Identify regulatory opportunities that facilitate commercial market entry
    • Manage the document control function
    • Product approval
    • Work closely with engineering
    • FDA Part 820
    • GCP Guidelines as they research new products in development
    • working closely with Marketing, R & D and post market surveillance
    • full exposure to working on market commercial entry
    • marketing and distribution
    • 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
    • Line Management experience needed
    • Product submissions experience
    • 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 Executive 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.


Desired Skills and Experience
Regulatory
IVDR
ISO

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Australia

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
I-Pharm Consulting
I-Pharm Consulting

Current Openings: 0

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. We have specialist teams working from offices in London, Munich, Frankfurt, New York, Charlotte, San Diego and Sydney, focusing on the UK, European, U.S. and APAC regions. Driven by our mission of “changing lives by placing people at the heart of life sciences’, we provide tailor-made solutions to our global client base. We have specialised solely in life sciences from the start. By focusing on selected functional markets, we have built a deep understanding of the needs, opportunities, challenges and cultural nuances in each of our areas of specialism. Coupled with a thorough understanding of each client, and a global network of candidates nurtured over our thirteen years, this puts us in a unique position: we provide unrivalled insight, advice and support to ensure the right technical and cultural alignment, every time. We an source talent across a range of services, offering our clients flexible solutions to successfully deliver projects on time and on budget. - Permanent Recruitment - Contract Recruitment - Executive Search Operating in a complex and fast-changing industry sector, we understand the importance of specialist knowledge. We work across the Pharmaceutical, Biotech and MedTech sectors, with a particular focus on the following specialist areas. Drug Development - Clinical - Biometrics - Quality Assurance & Tech Ops - Regulatory Affairs - Commercial - Medical & Scientific MedTech - Commercial - Quality Assurance / Regulatory Affairs - Research & Development Life sciences has never played a more important role for society, and we’re determined to deliver even greater support in the years ahead.
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