16 Director of Regulatory Affairs (Medical Devices) Jobs in Los Angeles, CA
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Director of Regulatory Affairs (Medical Devices)
$115k-149k (estimate)
Full Time
3 Months Ago
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Essenvia is Hiring a Director of Regulatory Affairs (Medical Devices) Near Los Angeles, CA
We are looking for a Director, Regulatory Affairs reporting directly to the CEO andshould have worked on creation, implementation and maintenance of Quality orRegulatory System processes, in compliance with FDA 21 CFR, Part 820, QualitySystem Regulationand ISO 13485. They should have experience preparing and maintaining internationalproduct registrations, filing facility registration and device listings, creating andmaintenance of regulatory files, consistent with global regulatory requirements.The ideal candidate should possess extensive experience working on leading RIM,PLM, QMS systems or platforms. They should be passionate about understandingcurrent state of regulatory affairs representing the various Regulatory users’ currentwith a healthy balance to meet future needs. This is a high impact problem role at theintersection of Reg Affairs, Quality, Product, Clinical and Commercial teams and willwork with the executive team to shape the “Future of work for Regulatory Affairs” todrive efficient outcomes for medical device companies.
JOB DESCRIPTION
JOB DESCRIPTION
CUSTOMER SUCCESS:The duties will involve maintaining and developing a relationship as a trusted advisor to select strategic customers, through onboarding and training clients, sharing industry best practices directly or through our network of consultants or regulatory specialists. This involves leveraging core regulatory affairs expertise and applying this to specific situation faced by customers in regulatory affairs areas. Responsibilities include:
- Hold product demonstrations for customers.
- Improve onboarding processes.
- Evaluate and improve tutorials and other communication infrastructure.
- Mediate between clients and the organization.
- Analyze customer data to improve customer experience.
- Handle and resolve customer requests and complaints
- Aid in product design and product development
PRODUCT OWNER, REGULATORY AFFAIRS:
You will be responsible for collaborating with the Product Manager, Design and Engineering leads to refine the product vision specifically, optimizing the value of product(s). Provide insights on client-to-business interactions to help Essenvia’s customer success team develop product support, and handle customer complaints and requests. The role will report to the CEO and will have a direct impact on building strategy to engage with customers, maximize value, share ideas and eventually grow our customer base. Responsibilities include:
- Identifying areas of improvement, and filling product gaps
- Generating new product ideas.
- Understand and refine product’s selling points.
- Act as the main point of contact between teams and stakeholders.
- Assist product development team to meet the objectives of a product release.
- Understanding product briefs and working with clients to fine-tune them.
- Identifying weaknesses in prototypes and making the necessary changes.
SUPERVISORY / LEADERSHIP RESPONSIBILITIES:
- Mentor regulatory staff to support customer success, and product owner function
- Exhibit skills in project management, leadership, communication and presentations.
- Identify issues and minimize regulatory risks through creative problem solving.
- Act as a product evangelist and representing the company at public events.
QUALIFICATIONS AND SKILLS REQUIRED:
Minimum of 8 years of Quality Management, Quality Assurance and Regulatory Affairs experience in the medical device industry, with responsibilities for managing others.
Experience in the Document Control process and the efficient control of all documentation required by regulatory agencies, and FDA and EU device and facility registrations.
Hands-on experience on eQMS, PLM, eCTMS, EDC, RIM and life science Document management systems etc. is a must
A four-year degree (an emphasis on health science would be a plus) or demonstrated proficiency through Regulatory Affairs Certification (RAC).
Ability to read, understand and interpret medical device, FDA and EU regulations and requirements, patents, legal documents, advance technical articles and professional scientific journals. Excellent communication skills required, written and verbal. Write procedures; perform presentations to staff and management.
Minimum of 8 years of Quality Management, Quality Assurance and Regulatory Affairs experience in the medical device industry, with responsibilities for managing others.
Experience in the Document Control process and the efficient control of all documentation required by regulatory agencies, and FDA and EU device and facility registrations.
Hands-on experience on eQMS, PLM, eCTMS, EDC, RIM and life science Document management systems etc. is a must
A four-year degree (an emphasis on health science would be a plus) or demonstrated proficiency through Regulatory Affairs Certification (RAC).
Ability to read, understand and interpret medical device, FDA and EU regulations and requirements, patents, legal documents, advance technical articles and professional scientific journals. Excellent communication skills required, written and verbal. Write procedures; perform presentations to staff and management.
Job Summary
JOB TYPE
Full Time
SALARY
$115k-149k (estimate)
POST DATE
01/27/2023
EXPIRATION DATE
04/19/2023
WEBSITE
essenvia.com
HEADQUARTERS
Canoga Park, CA
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The following is the career advancement route for Director of Regulatory Affairs (Medical Devices) positions, which can be used as a reference in future career path planning. As a Director of Regulatory Affairs (Medical Devices), it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director of Regulatory Affairs (Medical Devices). You can explore the career advancement for a Director of Regulatory Affairs (Medical Devices) below and select your interested title to get hiring information.
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