Senior RA Associate

SDI Limited; Melbourne; In loco; AUD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

SDI Limited, based in Melbourne, seeks a Senior Regulatory Affairs Associate to lead global registrations for US, EU, Australia, and other regions. You will define regulatory strategy for launches and ensure ongoing compliance with global requirements.

You will mentor the Regulatory Affairs team and collaborate with R&D, QA, Production, and Marketing to align regulatory needs with business goals while maintaining ISO13485, EU MDR, and MDSAP compliance.

Competenze

• Advanced degree or extensive regulatory experience.
• 5+ years in dental/medical device or pharmaceutical industry.
• 5+ years in regulatory affairs with local and international bodies.

Mansioni

• Prepare and submit registration documents across multiple regions (US, Canada, EU, Australia, NZ, Middle East).
• Maintain regulatory documentation and monitor changes.
• Provide strategic regulatory advice on new product launches and regulatory challenges.
• Mentor Regulatory Affairs team and collaborate with cross-functional teams.
• Support audits and regulatory actions including recalls and adverse events.
• Liaise with export staff and overseas offices.
• Ensure compliance with ISO 13484, MDSAP, EU MDR and related standards.

Conoscenze

Regulatory submissions

Regulatory strategy

Project management

Leadership

Communication

Regulatory risk

Cross-functional collaboration

Quality systems

ISO13485 knowledge

Mentorship

Formazione

Advanced degree

5+ years in dental/medical device

5+ years in regulatory affairs

Strumenti

Regulatory filing systems

Descrizione del lavoro

We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.

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.
• Assisting the Global Regulatory Affairs Manager in supporting and mentoring other members of the Regulatory Affairs team.
• Providing strategic regulatory advice on new product launches and regulatory challenges.
• Contributing towards SDI Strategic Priorities.
• Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.

Specific Responsibilities

• 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 products Technical Files, ensuring they are up to date and conformed 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 and external)

• All SDI personnel on site at SDI particularly QA, R&D, Production, Sales & Marketing.
• SDI overseas offices personnel.
• Customer's regs 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: 10 day fortnight.
• Local, interstate and international travel as required.

Essential Qualifications/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.

Essential Skills, Knowledge and Attributes

• Aware of SDI's current Quality policy and objectives
• 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.
• Familiarity with SDI's current quality policy and objectives.