Job Description:
Senior Regulatory Affairs Associate for Medical Devices in Sydney, Australia
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
We currently have an opening for a Sr. Regulatory Affairs Associate, with below details:
Scope and Responsibilities:
- Ensures regulatory compliance of the Health Care Business products for ANZ.
- Develops and maintains documentation relevant to assessment of risk to human health and the environment.
- Prepares and files regulatory document to Australia and New Zealand Healthcare Authorities for registration.
Responsibilities - Collaborates with cross-functional teams to compile and submit regulatory submissions for medical devices in accordance with local regulations and guidelines.
- Supports the development and maintenance of regulatory documentation, including technical files, design dossiers, and quality management system records.
- Interacts with regulatory authorities to address inquiries, provides necessary documentation, and resolves any compliance issues.
- Stays updated on industry trends, new regulations, and changes in the regulatory landscape, providing valuable insights to the
team. - Performs post market activities to support product compliance.
- Reviews Artwork/ Packaging materials supporting compliance and registration of product
Qualifications/Desired Background:
- A bachelor's degree in a relevant scientific or health discipline
- Strong Data Analytics/Reporting skill set
- Demonstrated experience in regulatory affairs within the medical device industry.
- Class III Device Application and Conformity Assessment experience
- Solid understanding of regulatory frameworks, such as TGA (Therapeutic Goods Administration) and Medsafe.
- Strong knowledge of ISO 13485, MDR (Medical Device Regulation), and other applicable standards.
- Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively.
- Strong interpersonal skills, with the ability to collaborate and interact with teams both locally and internationally
- Critical Thinking skills that inform regulatory strategy.
- Meticulous attention to detail and a keen eye for accuracy
- Ability to prioritize in a dynamic environment
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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