What are the responsibilities and job description for the Regulatory Affairs Manager position at AVITA Medical?
Position Title : Regulatory Affairs Manager
Location : Valencia preferred or Irvine, CA
Report to : Director, Regulatory Affairs
Compensation : 135K – 155K with annual bonus
AVITA Medical ® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies optimize wound healing, effectively accelerating the time to patient recovery. We believe that patients are at the heart of everything we do, our employees are the lifeblood of AVITA Medical, passion is key to making a difference, quality impacts everything we do, and integrity is essential to our success.
Position Summary :
The Regulatory Affairs Manager is a key contributor to the company’s regulatory group focused on support for AVITA Medical’s acute wound care products. The role includes providing early guidance, review, and approval of submission-related documentation.
Key Responsibilities :
- Manage one Regulatory Affairs Specialist direct report.
- RA lead for all activities associated with changes to the on-market product (supplier, design, manufacturing, etc.)
- Assesses changes for any regulatory action required in the US, EU, AU / NZ, and Japan.
- Prepares FDA submissions (PMA supplements, 30 Day Notices, Annual Reports, etc.), to ensure timely approvals and market release for product changes in the US.
- Establish and manage documented procedures for the creation and management of IFUs, procedure guides, and product labels.
- Define Labeling content in compliance with US and international regulatory requirements.
- Reviews and approves product testing and other submission related deliverables to ensure regulatory compliance.
- Collaborates with the new product development team and provide regulatory support as required.
- Reviews and revises SOPs, and other company and departmental procedures to ensure quality system compliance.
- Participates in device development design reviews and risk management activities.
- Establishes and maintains relationships within AVITA Medical Quality, R&D, and Operations teams.
- Provides onsite and remote audit support to the AVITA Medical Quality team, as needed.
Job Requirements :
EEOC : AVITA Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs.
Your Physical Work Environment Will Require : The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk and / or balance, use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination is necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus. The individual is frequently required to reach with hands and arms, and repetitive motion, The individual is occasionally required to stoop, kneel, or crouch. The individual may occasionally lift and / or move up to 25 pounds.
AVITA Medical is an E-Verify participant.
AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner. AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.
