Senior Regulatory Affairs Associate
vor 18 Stunden
Together with our customers, we are driven to make healthcare better.
#WeAreStryker
Stryker Senior Regulatory Affairs Associate Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.
The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
About the roleIf you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you.
We are looking for a Senior Regulatory Affairs Associate to join the high performing regulatory team.
The successful candidate will bring experience to complement 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 hard-worker, enthusiastic and collaborative.
ResponsibilitiesPrepare 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.Self-driven, strategic thinker with the ability to thrive in a fast-paced 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.What you'll be responsible forLegal Research: Conduct legal and factual research to collate findings, and inform business and legal decisions.
Legal Operations: Review laws and standards to implement, update and maintain the organization's policies, standards, and procedures.
Legal Advisory and Risk Management: Advise on the whole spectrum of legal matters that apply to the business and its offerings.
Skills you'll needNegotiation: Persuades others to shift their views and/or behaviours with the goal of reaching consensus.
Critical thinking: Identifies and synthesizes patterns and trends amongst various sources of information to reach a meaningful conclusion, perspective or insight.
Attention to detail: Accurately identifies and rectifies discrepancies or errors that exist in information and deliverables.
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