Quality Assurance and Regulatory Affairs Manager

4 weeks ago

Burswood, Australia Resonance Health Analysis Services Pty Ltd Full time

Our Quality Assurance and Regulatory Department ensures that we take a risk-based approach to all we do, whilst ensuring that we understand and meet the quality and regulatory requirements of the global markets we operate within.

This role is responsible for all aspects of the quality and regulatory compliance requirements for the organisation. Directing a team of four, this role is focused on implementing and driving a continuous improvement culture to maintain the effectiveness of the Quality Management System.

We have recently constructed a laboratory and commenced providing clinical trial management services to the market. Therefore this role will be focused on establishing a quality framework within the laboratory testing area, whilst providing quality oversight on clinical trial management and CRO activities, together with quality compliance in our medical device product design and development area.

**What you will be responsible for**:
**Duties & responsibilities**:

- Create and upkeep of documentation to ensure compliance to ISO13485 and ISO17025, ICH-GCP, GCLP, GMP.
- Ensure the Resonance Health meets applicable regulatory & statutory requirements in all areas (Australia, USA, Europe, United Kingdom)
- Management external stakeholders and ensure clear & effective communication with regulatory authorities.
- Documentation control & management, change control processes & tracking, vendor qualification & management, and deviation & CAPA management.
- Maintain regulatory technical file documentation.
- Participation in review & approval of marketing material
- Ensuring maintenance of the post marketing surveillance systems including adverse event reporting & trend analysis
- Provide regulatory support on additional projects as required.
- Assist with training and professional development of staff and peers.

**Experience & attributes**:

- Minimum of 7 years' experience in the Medical Device Industry or Laboratory testing, 5 of which spent in Quality (assurance, control, or systems) or Regulatory Affairs.
- Bachelor’s degree (or higher) in relevant field.
- Significant experience in QMS processes and management.
- Effective coaching, leadership, and motivational skills.
- Familiarity with ICH GCP requirements.
- Excellent written & verbal communication and interpersonal skills.
- Self-motivated approach and ability to thrive in a multidisciplinary environment and excellent time management skills.
- Expertise in both pre & post market regulatory activities.
- Proven analytical, problem solving & troubleshooting skills.
- Well versed in building & maintaining relationships with both internal & external stakeholders.

**What we offer you**:

- A _**permanent **_position in a growing company with an exciting vision.
- A friendly and _**happy team**_ environment, working with talented and smart people.
- _**Floating Public Holidays**_, so that you can substitute any Public Holiday for another day of your choice.
- Broad _**flexible working arrangements**_ to enable you to balance collaboration with your other life commitments.
- Head office overlooking a park in a great location with _**parking, great public transport**_, and _**end of trip facilities**_.
- _**Market competitive **_remuneration.
- We _**promote internally**_ and focus on the development of our employees.

**Salary**: $140,000.00 - $160,000.00 per year

**Benefits**:

- Free food
- Work from home

Schedule:

- 8 hour shift

Application Question(s):

- How many years experience do you have in a similar role?

**Education**:

- Bachelor Degree (preferred)

Work Authorisation:

- Australia (required)

Work Location: In person

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