Regulatory Affairs Associate in Sydney, Australia

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We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

If you are passionate about medical devices and regulatory affairs then Stryker wants to talk to you. We are looking for Senior Associate to join the high performing regulatory team. The successful candidate will bring experience to compliment the pre-market team of three.

We are looking for someone who has at least 3 years experience within Regulatory Affairs. The ideal candidate will come with experience with Class III and TGA conformity standards. 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 hard-worker, 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.

Skills & Requirements:

• Tertiary education in a technical discipline (e.g. Science, Engineering, Biomedical or related).

• Proven experience in Regulatory Affairs with demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.

• Knowledge of Australian regulatory environments for medical devices (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.

• Minimum 2 years experience in a similar Regulatory Affairs role.

• Relevant degree in science or biomedical engineering.

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.

• Ongoing training and opportunities for career progression

• Paid Parental leave schemes

• Volunteer Days

• Access to employee benefits

• Access to our career and self-development program from day one

Click apply to join us today

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.