Regulatory Affairs Coordinator

2 weeks ago

St Leonards, Australia Stryker Full time

Stryker is recruiting for a Regulatory Affairs Assistant to join the dynamic Government and Regulatory Affairs team. This person will support across the Reg team, working particularly closely with the post-market team, but gaining exposure across the umbrella of Regulatory Affairs. This person will help support bringing new technology into the Australian/New Zealand market, navigating the changing Regulatory landscape, and ensuring product is safe and effective in the marketplace.

**Responsibilities**:

- Help gather and draft submission documentation.
- Maintain current product registrations and assist to process registration changes when required.
- Processing of complaints within the Complaint Handling System in a timely manner.
- Escalate and action complaint follow up attempts.
- Support complaint investigations/product field actions.
- Ensure effective record keeping across regulatory documentation.
- Participation in continuous process improvement aligned with key business metrics.
- Build relationships and liaise with key stakeholders from regulatory, operations, marketing and sales teams

**Skills & Requirements**:

- Invested interest in medical devices and an ability to communicate and prove this.
- Proactive problem-solving skills with an ability to bring alternative solutions under pressure and tight timeframes.
- Excellent communication skills, ability to negotiate, influence others and clearly give and receive instructions and direction.
- Deadline driven, ability to prioritise and deliver tasks in a timely manner.
- High attention to detail, ability to spot differences and correct errors, being the extra pair of eyes in a busy team.
- A passion for compliance and process driven style of working.
- A ‘bigger picture’ mindset, able to see future and current strategies to best support the team.

**Culture & Benefits**:
At Stryker, you can expect an attractive package including a broad range of discounts and benefits from a range of partners This is a genuine opportunity for an ambitious and customer focused individual to progress and grow your career with a leading global medical device company that offers countless development opportunities.

**Some of our benefits include**:

- Join one of Australia’s Best Places to Work in 2020
- Multiple financial benefits including health care, financial wellbeing, insurance benefits.
- Ongoing training and opportunities for career progression
- Paid Parental leave schemes
- Volunteer Days
- Onsite gym
- Being part of one of the world’s largest and most recognizable brands.
- Excellent team culture - we have fun whilst we work
- A Leader who will support & guide you throughout your career
- Access to employee benefits
- Access to our career and self-development program from day one
- Work with likeminded individuals who are driven by exceeding targets and improving patient outcomes

**About Stryker**:
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

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