Regulatory Affairs Team Leader

Overview:
**Full-time |** Work from Home Arrangement** **| **Annual Leave Loading**

**Quarterly Bonus Program | Onsite parking | **Subsidised** Cafeteria**

**Diversity & Inclusion | Wellness Program | Community Engagement**

Fantastic opportunity to contribute your skills and experience to this permanent leadership role.

At Cook Medical, we are passionate about the work that we do in making a difference to patient lives around the globe. We treat everyone with respect and encourage our employees to be transparent, through open and honest communication and being appreciative of individual contribution.

**Responsibilities**:
The primary role of the Regulatory Affairs Team Lead within the regulatory team is to lead and manage a team working on the collection and evaluation of clinical evidence and data collected for post market surveillance.

In addition, the Regulatory Affairs Team Lead will also:

- provide input to regulatory strategies
- perform clinical and post-market surveillance (PMS) activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets
- provide regulatory affairs input for the functional areas.

**Key Responsibilities**:

- Provide leadership to a team within the regulatory affairs function, including management of the day-to-day resource allocation and assignments for the team.
- Encourage and foster employee development through mentorship, training, and feedback.
- Establish and monitor goals and objectives for the team to achieve the immediate or short-term regulatory objectives.
- Perform systemic literature reviews using search databases, developing clinical evaluation plans, clinical evaluation reports and related submission documents to support product registration in global markets.
- Provide input and adhere to scheduling and management of PMS plans, reports, PMCF plans and reports and clinical evaluations.
- Review and update existing clinical evaluation reports with new data from post-market surveillance, published literature, risk management and other relevant data sources.
- Work in close collaboration with medical affairs, clinical affairs, engineering and other stakeholders globally and locally.
- Provide input to risk assessment as well as clinical/regulatory strategies.
- Participate in development projects and prepare project deliverables including examination of clinical evidence, as needed.
- Coordinate multiple projects and provide regular reporting to regulatory affairs manager as required.
- Participate in internal and external regulatory audits.

Qualifications:

- A thorough understanding of the global medical device regulations in relation to post-market surveillance (PMS), post-market clinical follow-up (PMCF), clinical evaluation plans (CEPs) and clinical evaluation reports (CERs)
- Tertiary qualification in either science, engineering, pharmacy or microbiology with ability to read and process/analyse scientific literature essential
- Understanding of clinical experience data such as clinical outcomes and complaints
- Good technical writing skills to produce high-quality clinical documents and proven problem-solving skills.
- Experience working in a highly regulated industry such as medical devices essential
- Experience preparing submissions to external regulators and reviewers essential
- Strong leadership skills to effectively guide, inspire, motivate and communicate with team members to meet department and organisation objectives essential
- Excellent time management, planning and organising skills essential
- Highly developed communication and interpersonal skills
- Good computer skills including knowledge of Microsoft (Excel, Word, PowerPoint) essential

**Benefits***:

- Stability of a long-established company
- Values recognition and service awards
- Performance based quarterly bonus
- Annual Leave Loading
- Top Hospital Private Health Cover for immediate family
- Flexible start/finish times
- Ongoing training and development
- Strong inclusive culture that values our people

**About us**:
Since 1963, Cook Medical have been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients’ lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities.

At Cook Medical, we use our high ethical standards and core values to guide our decisions and actions. We approach innovation by first listening to understand and then creating a solution.

**Supporting a Diverse Workforce**:
**Community Commitment**:
Our community program seeks to have a positive, transforming impact on our people, the environment and our local community. The program has four pillars:

- Community Engagement: We support our local community through philanthropy, education and partnerships. Our employees have been at