**Who we are**:
At Leica Biosystems our promise is to enable clinicians to efficiently provide patients a highly confident diagnosis within 24 hours of biopsy. We offer the most comprehensive portfolio that spans the entire cancer diagnosis workflow from biopsy to diagnosis. Our experts are committed to delivering Improved Quality, Integrated Solutions, and Optimized Efficiencies leading to breakthrough advances in diagnostic confidence and turnaround time.
**Major Responsibilities**
- Management responsibility for the Melbourne Regulatory Affairs department and a team of regulatory professionals. Responsible for leading all aspects of the site's regulatory obligations including but not limited to, product registrations, regulatory intelligence, communication with regulatory authorities, post-market surveillance and vigilance activities, regulatory compliance assessments, and providing regulatory input/strategy for new product development and device changes.
- Authorised to place product on ship hold.
- Responsible for establishing and maintaining effective collaboration with the Quality Assurance team and solving problems as a team.
- Develops and mentors team members using Danaher tools (Development 4 Growth and Performance 4 Growth).
- Utilises critical thinking skills to anticipate issues and risks and to propose solutions and mitigations to deliver the business priorities.
- Serve as a resource and mentor to colleagues with less experience, including RA Officers and Senior RA Specialists.
- Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function.
- Work closely with RA/QA management in developing objectives.
- Builds partnerships cross-functionally across LBS and Danaher sites; may serve as representative on taskforces, councils or improvement initiatives.
- Maintain working knowledge of relevant regulations and quality system requirements that affect the business.
- Other duties as assigned by management.
**Required Skills/Experience/Education**
- Bachelor's degree in science, medical or technical field and experience with increasing responsibility in medical device regulatory affairs.
- At least 6+ years' experience with increasing responsibility in medical device regulatory affairs.
- Dynamic leader with a minimum of 5+ years managing people with a proven track record of success in developing and leading a team. Creates an environment of engagement and continuous improvement.
- Regulatory Affairs experience with IVD medical devices essential.
- Must have requisite training or certification in medical device regulatory affairs through on-the-job training, seminars, training.
- Experience in conducting and hosting regulatory inspections. Experience with MDSAP.
- Knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.
- Experience in IVD medical device NPD, design controls for medical instrumentation contain software and risk management.
**Competencies**
- Ability to manage and develop a team of regulatory affairs professionals.
- Ability to translate LBS RA/QA vision and objectives into challenging and meaningful goals for the RA team. Moves strategy to action.
- Ability to identify, analyze and mitigate risk (e.g. product, material, compliance, supply).
- Ability to work as a member to the RA/QA management team.
- Deputize for the RA/QA Manager at Site Management Team Meetings.
- Strong organizational skills. Ability to multitask.
- Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators.
- Strong commitment to quality and compliance. Organized and detail-oriented.
- High level of initiative, self-motivation and energy.
- Reliable and responsive.
- Customer focused.
- High level of integrity. Consistently uses sound judgment. Operates with transparency and is trusted. Demonstrates humility and self-awareness.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you've ever wondered what's within you, there's no better time to find out.