Company Overview
Our client is an innovative Medical Device organisation who focus is on the development and manufacture of radiotherapy systems that make cancer treatments shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Their radiation treatment delivery systems in combination with fully integrated software solutions set the industry standard for precision and cover the full range of radiation therapy and radiosurgery procedures.
They are looking for a Director/Senior Director Regulatory Affairs to join their leadership team at this critical time in their development to lead a dynamic/growing company’s Global Regulatory function the objective of ensuring the successful launch and continued marketing of the organisation’s life enhancing products.
Core Objectives
- Drive and lead the successful submission process for products worldwide, ensuring a transition from R&D to market.
- Build, develop, mentor a regulatory team with credibility with both internal and external stakeholders.
- Build and develop the regulatory culture
- Build and develop the company’s regulatory strategic program to meet and facilitate the company’s growth aspirations.
Candidate Requirements
- Bachelor of Science degree or equivalent in engineering/life sciences/suitable work experience in a technically related field in lieu of formal education.
- At least 10 years of experience in regulatory affairs, quality systems, process improvement/Lean, or product development/project management.
- At least 5 years of experience with medical device capital equipment or software products.
- Experience with managing complex regulatory or quality documentation for markets such as the: USA, China, Canada, EU, Japan, South Korea.
- Excellent knowledge of process development and continuous process improvement.
- Strong knowledge of worldwide regulatory and quality system requirements.
- Strong team leadership and people development skills.
- Excellent communication, organizational and customer relations skills.
- Ability to travel domestically and internationally up to 10%.
Our client is looking for an ideally be site located, however can offer a hybrid structure with a minimum of 2 days a week onsite.
LDI SEARCH
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Crew Call: Various Positions for ULB TV Movie
Job Description:
An ultra-low-budget (ULB) TV movie is seeking dedicated crew members for a 13-day shoot in the metro Atlanta/Marietta, GA area. This is a local hire or work-as-local opportunity, with no lodging or travel provided. We’re looking for passionate professionals ready to bring their expertise to a collaborative environment.
Open Positions:
- Coordinator
- Production Designer & Props
- Costume Designer
- Sound Mixer
- 1st & 2nd Assistant Directors (AD)
- Gaffer & Key Grip
- 1st & 2nd Assistant Camera (AC)
- Hair & Makeup Artists
- Production Assistants (PAs)
Job Responsibilities:
- Collaborate with the production team to execute a high-quality TV movie within budget constraints.
- Deliver professional and efficient work in your designated department.
- Maintain a positive and adaptable attitude on set.
- Follow the production schedule and meet all deadlines.
Requirements:
- Previous experience in your respective role is highly preferred.
- Must be local to the metro Atlanta/Marietta area or willing to work as a local.
- Reliable transportation to and from set.
- Strong work ethic, attention to detail, and a team-oriented mindset.
Compensation Details:
- Ultra-low-budget rates in accordance with ULB guidelines. Specific rates will be provided upon offer.