Location Country
Australia
Vacancy Name
Senior Regulatory Affairs Associate
Employment Type
Full-Time
Summary of Role
The Senior Regulatory Affairs Associate is responsible for:
Ensuring compliance with global legal and regulatory requirements for medical devices, driving product registrations in SDI’s core markets and managing the regulatory lifecycle of products.
Monitoring and maintaining local and overseas compliance with regulatory affairs requirements.
Providing strategic regulatory advice on new product launches and regulatory challenges.
Conducting work in a safe manner, with a quality mindset and demonstrating a strong commitment to SDl's values of passion, accountability, respect, teamwork, and innovation.
Assisting the Global Regulatory Affairs Manager in supporting and mentoring other members of the Regulatory Affairs team.
Specific Responsibilites
Prepares and submits registration documents in the following countries/regions such as US, Canada, EU, Australia, New Zealand, Middle East and as directed by line manager.
Maintains accurate and complete regulatory documentation.
Stays current with legal and regulatory changes and assists with ensuring regulatory strategies reflect upcoming changes.
Utilizes knowledge and experience to identify and tackles problems within the regulatory areas.
Conducts legal and regulatory risk assessments for changes and implements appropriate mitigation strategies.
Reviews and approves artworks such as marketing materials, product labelling or user manuals to ensure compliance to applicable standards and regulations.
Monitors changes to products (eg: labelling, product codes, formulation) & submit variations to relevant regulatory bodies as required.
Reviews and assists with the maintenance of product Technical Files, ensuring they are up to date and conform to ISO 13484, MDSAP, EU MDR and device’s applicable standards requirements such as ISO4049, ISO9917, ISO 10993 series etc.
Liaises with Export staff on overseas requests for regulatory documentation.
Liaises with SDI on registration requirements and progress of ongoing production registration submissions.
Monitors overseas re-registration requirements. Ensures that the renewals are submitted well in advance of certificate expiring.
Develops and updates regulatory procedures ensuring all documentation is current and compliant with all applicable legal and regulatory requirements.
Assists in any regulatory actions including recalls, adverse events reporting.
Provides submission guidance to Regulatory Affairs Associate(s), regulatory policies, and procedures.
Identifies and implements process improvements to enhance regulatory efficiency and effectiveness.
Participates and supports audits as required.
Collaborates with cross-functional teams (R&D, Marketing, Production and QA) to ensure regulatory requirements are met.
It is important to understand that this position requires clear commitment, effort and contribution to the broader goals and objectives of SDI. These expectations include:
Clear and meaningful communication with other departments throughout SDI.
Ability to work independently and collaboratively in a fast-pace environment.
Analytical mindset with the ability to assess regulatory risks, propose appropriate solutions, and make sound decisions.
Key Relationships (Internal & External)
All SDI personnel on site at SDI particularly QA, R&D, Production, Sales & Marketing.
SDI personnel, located in overseas offices.
Customers’ regulatory affairs personnel.
Competent authorities such as TGA, EU, FDA, Health Canada, etc.
Regulatory affairs consultants.
Job Environment
The position is located at Bayswater.
Working hours: 38 hours per week
Local, interstate and international travel as required.
Education Level
Bachelor's Degree
Essential Experience
Advanced degree or extensive experience in regulatory affairs.
5+ years' experience in the dental/medical device/pharmaceutical industry.
5+ years' experience in a Regulatory affairs role dealing with local and international regulatory bodies.
Knowledge and skills
Ability to work independently and to develop and execute regulatory strategy.
Strong working knowledge of relevant medical device regulations, such as FDA, EU MDR, TGA, Health Canada, Medsafe and any other applicable competent authority’s requirements in the country/region assigned.
Strong communications and project management skills.
Expert in regulatory submission preparation and regulatory information management systems.
Proven leadership and mentorship abilities.
Strong working knowledge of ISO13485, EU MDR, MDSAP and device’s applicable standards.
Ability to work collaboratively with both internal and external people across a range of operational functions.
Resourcefulness in identifying solutions to product registration and regulatory challenges.
A "can do" attitude and willingness to try different approaches to achieving business outcomes.
Personal Qualities
Outstanding communication and analytical thinking skills
Attention to detail
Good organisation and document management
Professional communication
Integrity and confidentiality
Ability to work both independently and collaboratively
Classification Level
Non-Award
Salary Minimum
$100,000.00
Salary Maximum
$130,000.00
Benefits
Increased team capacity to support the new product registrations and the existing backlog.
