Post-market Manager

4 weeks ago

Sydney, Australia Device Technologies Australia Full time

**About us**

**Since 1992, Device Technologies has been dedicated to improving patients’ lives through leading edge technology and services, **supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world. Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and ongoing support provided by our people. With HQ in Sydney, the company continues to grow, representing over 200 trusted brands, and employing over 1000 highly skilled staff located across Australia, New Zealand and Asia.

Geared towards optimal performance, our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We focus on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce.

**The opportunity**

Exciting opportunity to work within the RAQA team managing product complaints, adverse events and recall activities in the ANZ medical device environment. This is a key supporting function providing collaboration opportunities within the company, with our overseas principals and government authorities to support our post market vigilance obligations.

**Key Responsibilities**:

- Ensure all post-market vigilance and monitoring activities are conducted in compliance with the local regulatory and legal requirements for Device Group product ranges for relevant territories.
- Ensure accuracy and currency of data held on all databases.
- Collaborate with RAQA Management, Business Management and other departments to identify and resolve areas of concern in relation to Device Group post-market quality assurance and product quality.
- Review and advise on external regulatory reports and requirements.
- Develop and maintain e reporting of operational performance indicators.
- Ensure delivery of a high level of internal and external customer service by the RAQA Post-Market Team.
- Develop and maintain excellent working relationships with relevant regulatory bodies and government departments.
- Review and ensure the currency of QMS documents for RAQA post-market activities and related processes.
- Identify, lead and facilitate continuous improvement projects.
- Promote the importance of post-market vigilance and increase the awareness through training.

**About you...**

At Device Technologies, we succeed through our commitment to four key values:
**Delivering Innovation** - We encourage and reward fresh ideas and are committed to supporting our people to make change.

**Seeking Collaboration** - We support each other in our combined mission to help others achieve their goals.

**Taking Ownership** - We believe in equipping our people to take responsibility and accountability in their roles and trust them to get the job done.

**Practising Good Business** - Our success is built on a mix of intuition and experience and we foster an environment where all voices are heard and nobody is afraid to make mistakes.

**Experience required**:

- Tertiary qualification in Science, Engineering or relevant fields.
- Well-developed leadership, interpersonal, communication and organisational skills.
- Knowledge of, and at least 5-year experience in the Australian medical device regulatory/quality sector.
- Good knowledge of medical device post-market vigilance and monitoring requirements.
- Knowledge of ISO 9001,13485 and quality system requirements.
- Demonstrated commercial acumen.
- Excellent problem solving, analytical and decision-making skills.
- Excellent attention to detail.
- Good understanding of medical terminology.
- Experience developing and delivering training.
- Experience managing a team of direct reports.

**Interested?**

At Device Technologies we are motivated by the opportunity our equipment provides to change people’s lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of our business.

Our promise is all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different.
- It is also a mandatory requirement for certain roles within our organisation, where the successful applicant may be required to present certifications and/or vaccinations status as per role requirements. Evidence of certificates or vaccination status will be requested during the interview process by management to qualify fit for role and prior to any offer._

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