Senior Regulatory Affairs Associate
Senior Regulatory Affairs Associate
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Job Description
If you are passionate about medical devices and regulatory affairs then Stryker wants to talk to you. We are looking fora Senior Regulatory Affairs Associateto join the high performing regulatory team. The successful candidate will bring experience to compliment the existing RA team of four.
We are looking for someone who has at least 5 years experience within Regulatory Affairs. The ideal candidate will come with experience of Class III and TGA conformity assessment applications.
This role will suit an individual who is currently operating at Senior level or is ready to step up from Associate into Senior level. Whilst experience is key the successful candidate will be a true team player a hardworker enthusiastic and collaborative.
Responsibilities
- Prepare and submit device registration applications including complex submissions such as Class III and/or TGA Conformity Assessment applications.
- Review and determine the impact of change notifications for existing devices including management of registration updates and stakeholder communication.
- Provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions.
- Work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA) Medsafe and Corporate requirements.
- Operate with a significant degree of efficiency and independence.
- Management of annual reports and renewal of licenses to ensure compliance with local regulatory requirements.
- Maintain corporate compliance by supplying information as required by the Therapeutic Goods Administration (TGA) and Medsafe.
- Develop new regulatory processes and continuous process improvements.
- Develop and maintain strong relationships with MedTech Industry and the TGA to leverage advocacy opportunities including health policy in line with the business strategy
- RA Assistant/Associate level mentorship
Skills & Requirements:
- Minimum 5 years experience in a similar Regulatory Affairs role.
- Tertiary education in a technical discipline (e.g. Science Engineering Biomedical or related).
- High attention to detail and deadline oriented
- Selfdriven strategic thinker with the ability to thrive in a fastpaced and high growth company
- Proven experience in Regulatory Affairs with demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.
- Strong knowledge of the Medical Device regulations in Australia and New Zealand. International regulatory knowledge desirable e.g. FDA and EU MDR
- Strong negotiation and communication skills to effectively build relationships with key stakeholders industry bodies and regulatory authorities.
Culture and 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:
- Multiple financial benefits including health care financial wellbeing insurance benefits.
- Paid Parental leave schemes
- Volunteer Days
- Being part of one of the worlds 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 our career and selfdevelopment program from day one
- Work with likeminded individuals who are driven by exceeding targets and improving patient outcomes
If you are interested in finding out more click apply today!
Travel Percentage: 10Required Experience:
Senior IC
Employment Type
Full-Time
