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VP of Quality, Regulatory & Clinical Affairs

Employer
mexec
Location
Melbourne, Australia
Salary
Competitive
Start date
19 Jan 2022
Closing date
17 Feb 2022

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

  • MedTech
  • Digital Health
  • Executive Team

Our client aims to be the leading digital solution for the management of respiratory disease; integrating devices and data to optimise outcomes for patients, healthcare professionals and payers.

The Opportunity
Reporting to the CEO, your key remit will be to strategically direct and oversee the company's quality management, regulatory, and clinical affairs functions to achieve compliance and market access.
  • Develop quality, regulatory and clinical affairs strategies that achieve the commercially required market-access with the optimal balance of cost effectiveness, time to market, and regulatory compliance vs risk.
  • Collaborate and communicate across the company to ensure all relevant departments have input to the development of the QA/Reg/Clin strategies, understand the strategies, are adequately trained, and understand their role in contributing to achieving market access through RA/QA compliance.
  • Oversee or manage the Company's clinical and user trials and home-health programmes, including pre-commencement and active programmes.
  • Ensure that the Quality Management System (QMS) complies with all applicable standards and regulatory requirements, including ISO13485, the Australian Medical Device Regulations 2002, the European Medical Device Regulations 2017/745 (MDR), and the US Code of Federal Regulations 21 CFR 820.
  • Ensure that processes needed for the QMS are established, implemented, and maintained, and that the QMS is suitable and effective.
  • Create the Regulatory Strategy. Develop strategic options for regulatory compliance and approval and/or clearance pathways in target markets.
The Requirements
  • Minimum of 5 years medical device/electronics/health IT industry experience across global markets.
  • Quality management or clinical studies experience in a regulated medical device industry. Experience in more than one of these areas highly regarded.
  • Familiarity with requirements and processes of ISO 13485 and FDA QSR quality systems.
  • Practical knowledge of design controls, risk management, process validation, quality system software validation, production and change controls as they apply to a regulated software and electronics developer and manufacturer.
  • Familiarity with software, electronics, and wireless communications design activity.
  • Familiarity with information security management system and data privacy requirements.
  • Experience working with teams based in multiple global locations and time zones.
  • Outstanding organisational and problem-solving skills essential, required for management of multiple projects.
The Offer
You will join one of Australia's most exciting expanding health technology companies. Our client is open to reviewing candidates across a range of experiences for this role. Quality Management expertise would be highly regarded with exposure across additional competencies also preferred.

For this permanent and exciting opportunity please email your cover letter & CV to careers@mexec.com. Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.

mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.

We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.

Company

Find out more about working for our company

mexec-career-hub-button

Brief Company Description; 

mexec is an Executive Search Recruitment firm that also provides support to individuals seeking to transition to a new role. 

We specialise in the science, health and innovation sectors. 

mexec are experienced in resourcing staff for companies including executive search and selection services to build your leadership team. 

We offer comprehensive services for individuals including our mexec jobstrategyTM program, résumé writing, LinkedIn profile updates and interview coaching. 

mexec works at all levels from graduate to CEO and board.

 

hub-icon-mexecPlease visit our Careers Hub on https://www.pharmiweb.jobs/minisites/mexec-agency-careers-hub/

 

 

 

Company info
Website
Mini-site
mexec
Telephone
1300 0 63932
Location
16 Harold Street
Blackburn
VIC
3130
Australia

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