Senior Regulatory Affairs Associate
- Sydney
- Salary:Competitive salary package + beneifts
Benefits
• Work with a leading Healthcare company with a global presence
• Collaborative environment with a supportive team in place
• Competitive salary package + bonus
About the Company
Our client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medical Devices.
About the Opportunity
Join as a Senior Regulatory Affairs Associate, where you will play a pivotal role in our client's regulatory processes. Responsible for managing submissions, developing regulatory strategies, and fostering key relationships, you will contribute significantly to the success and competitiveness of our client in the dynamic medical device industry. Reporting to the Regulatory Affairs Manager, this position offers a unique opportunity to impact the business at a strategic level, ensuring compliance and efficiency in a global context.
Duties
• Lead and manage regulatory submissions to ensure timely approvals.
• Develop and implement effective regulatory strategies for streamlined submissions.
• Prepare and compile comprehensive regulatory documentation packages.
• Evaluate the impact of changes on the regulatory status of products.
• Build and maintain positive relationships with regulatory authorities.
• Provide valuable regulatory advice to diverse cross-functional teams.
• Support health economic submissions and contribute to tender processes.
• Actively participate in compliance-related activities, including audits.
• Review and enhance processes related to regulatory activities, ensuring efficiency and adherence to industry standards.
Skills and Experience
• Relevant degree in a science discipline.
• Minimum 3 years Regulatory Affairs experience in Medical Devices.
• In-depth knowledge of global regulatory requirements, ensuring compliance and strategic planning.
• Showcase a track record of independently preparing and submitting complex regulatory documents with precision and efficacy.
• Strong communication skills
• Collaborative approach
Culture
Our client cultivates a dynamic and collaborative company culture, emphasizing innovation, integrity, and a commitment to improving healthcare. Join a team dedicated to making a meaningful impact on patient lives in a supportive and inclusive work environment.
How to Apply
Click 'Apply' or contact Gemma Staddon, Specialist Manager, at 02 8877 8776 for a confidential discussion.
6 months ago
Regulatory Affairs
Benefits • Work with a leading Healthcare company with a global presence • Collaborative environment with a supportive team in place • Competitive salary package + bonusAbout the CompanyOur client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across M...
7 days ago
Regulatory Affairs
BenefitsMust have unrestricted work rights for 12 monthsWorking within a global teamMonday to Friday onlyAbout the companyWork within a large global Biotechnology company that boasts a good company culture that is always expanding.About the opportunityThe Regulatory Affairs Officer wil...
21 days ago
Medical Affairs
About the companyGlobal healthcare leader dedicated to making life better for people worldwide. Working tirelessly to discover and deliver life-changing medicines, improve disease management, and contribute to communities.About the opportunityThis role plays a crucial role in the medical affairs, development, and business unit brand team, contributin...
22 days ago
Medical Affairs
Role: Senior Medical Science Liaison (MSL) - OncologyBenefitsCompetitive salary with car allowance, bonus, super, and additional benefits.Opportunities for professional growth and a healthy work-life balance.Inclusive, diverse work environment with generous leave entitlements.About the Company
28 days ago
Medical Affairs
Role: Senior Medical Science Liaison (MSL) - OncologyBenefitsCompetitive salary with car allowance, bonus, super, and additional benefits.Opportunities for professional growth and a healthy work-life balance.Inclusive, diverse work environment with generous leave entitlements.About the Company
24 days ago
Medical Affairs
Senior Medical Science Liaison (VIC) - Gastroenterology and Immunology BenefitsJoin a globally renowned organisation as part of their exciting Australia/Oceania expansion Highly rewarding remuneration package including bonus and car allowanceManaging both a pioneering product portfolio across Gastroenterology and Immun...
6 days ago
Medical Affairs
Benefits• Newly created position working across Evidence Generation & Medical Excellence • Work with a highly skilled medical team in a leading organisation • Competitive Salary package on offer + benefitsAbout the CompanyOur client, a global pharmaceutical organisation focusing on delivering transformative therapies across various thera...
22 days ago
Human Resources
BenefitsConvenient and well-connected location.Work-life balance with a flexible WFH policy.Professional growth opportunities.About the companyThis company are a well-established modern organisation, acting as part of a larger branch; providing care to individuals and communities in the aged care sector.
25 days ago
Clinical Research
BenefitsWork for a not-for-profit organisationLead transformative change in cancer careSydney based, with flexible hybrid working12 month contract (initally)About the companyThis company is a leading not- for -profit research organisation specialising in advancing medical science and imp...
20 days ago
Human Resources
Benefits:Competitive salary with room for growthProduction site located in Blacktown 2148Collaborate with senior stakeholders About the Company:A global company specializing in chemical manufacturing, with a focus on safety and environmental sustainability. Operating across the ANZ region,...
15 days ago
Sales
About the companyOur client is a global medical device company taking pride in their capabilities to reinvent the way orthodontic and restorative treatment is presented and delivered to patients through their network of technically training doctors. About the opportunityBecause of you, patients will smile more confidently with the support of...
20 days ago
Administration and Business Support
Benefits!Established industry leader in the Healthcare spaceLocated in North Ryde, close to public transportFree parking on siteFlexible WFH hybrid modelPermanent roleASAP start for the right candidateAbout the company...A global healthcare brand, bas...