Senior Specialist Regulatory Affairs

JOB DESCRIPTION:
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Our medical devices help more than 10,000 people have healthier hearts. This exciting role supports the regulatory processes for Structural Heart (SH) and Heart Failure (HF) product portfolios. This is role is based in Sydney.
Overview:

• Provides regulatory support on a range of devices and activities which include new product introduction, evaluation of post market design changes, product submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with medical device regulations and goals of the business.

Core Job Responsibilities:

• Manages regulatory submissions to obtain and maintain SH and HF product approvals in accordance with agreed business priorities.
• Develops regulatory strategies and tactical plans for product registration submissions to expedite approvals and ensure maximum competitiveness of the businesses for which the position is responsible. Identify and communicate potential risks and risk mitigation strategies to stakeholders.
• Prepares product submission packages for regulatory registrations and renewals. Reviews and provides direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards.
• Determine impact of product and system changes on regulatory status of product registrations and execute as required.
• Develops and maintains positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development and submission review
• Provides regulatory advice to marketing, global regulatory and Health Economics teams, clinical project teams, and other functions as required.
• Supports health economic submissions where necessary to support prostheses listing. Supports tender submissions.
• Participates in compliance related activities, including Quality System Audits, as required.
• Assists in the review and development of processes related to regulatory activities.
• Participates on cross-functional teams representing the Regulatory Affairs function as required.
• Attend regular departmental meetings with ANZ RA Director and ANZ RA team members to build in continuous feedback mechanisms.
• Meet the requirements of ISO by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
• Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment.

Requirements:

• Bachelor's Degree in Science/Medical/Engineering or related fields
• Minimum 5 years Regulatory Affairs experience in medical devices industry.
• Broad base of knowledge and understanding of regulatory requirements
• Proven ability to prepare and submit documents to regulatory agencies independently or with minimal supervision.
• Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
• Ability to effectively interface with multiple company disciples and responds to complex questions related regulatory requirements.
• Demonstrated skills in contributing to multiple projects simultaneously.
• Must be detail oriented, well-organized, and able to work both independently and in teams.
• Strong communication skills

Due to the inherent requirements of the role, the preferred candidate must provide evidence of full COVID-19 vaccination before the commencement date and maintain a fully vaccinated status for the period of employment.
Abbott provides some fantastic benefits for our employees, these include:

• Free onsite parking, onsite gym and barista at our Sydney office
• Leading Learning and Development opportunities
• Wellness programs
• Discounted share options
• Being part of an organisation reputed to be a World’s Top Employer recognised for our workplace culture that values healthy living, diversity and equal opportunity

Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.
In order to be eligible to work for Abbott in Australia or New Zealand, you must hold current working rights with no restrictions for the respective country applicable.
We ask that recruiters respect our internal recruitment process and PSA panel by refraining from contacting us or forwarding unsolicited profiles.
The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Regulatory Operations
DIVISION: MD Medical Devices
LOCATION: Australia
Macquarie Park : 299 Lane Cove Road
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)