Manages and train Regulatory Affairs representatives and associated processes for preparation of product submissions, including 510(K), CE Technical Files (MDD and MDR), China, Canada, Japan, South Korea, and Australia and other International Countries.
Interact with Internal and External teams on regulatory related projects to meet regulatory compliance topics and regulatory tasks.
Lead the development and implementation of regulatory strategy for assigned projects of the relevant BU
Collaborate with Sr. Director Regulatory regarding EU, China, Japan, South Korea, Taiwan and other global territories regulatory teams for to implementation of develop global regulatory strategies for projects and submissions.
Approving labeling (including advertising and promotional materials) in the context of submissions or registrations and serving as the regulatory expert of the projects.
Provide regulatory advice and guidance to Regulatory Affairs representatives, engineering, and project teams to ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.
Manage, mentoring and train International Regulatory Associates/Leads for product submissions.
Will support and partner with Internal teams and functions in phases of design, development, production, and distribution of medical devices.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Requirements: Requires a Bachelors or Masters Degree in related field.
Minimum of 4 to 6 years of experience in regulatory medical device sector.
Demonstrated knowledge of medical principles.
Requires working knowledge for medical device regulatory submissions in USA, EU and other Global Territories. Prefer additional knowledge for regulatory submissions for Japan, China, Canada, South Korea, Taiwan, and Australia.
Must have excellent interpersonal, collaboration skills with demonstrated ability to collaborate and be a partner with Internal and External teams
Must have capability to lead cross department projects with project management skills.
Proven mastery & demonstrated understanding of regulatory affairs aspects related to medical devices.
Can manage and to motivate a group of individuals
Experience in business or operations side of a medical device company is preferred.
Knowledge of all aspects of the quality process, including standards, methods, and procedures for regulatory compliance.
Direct experience with Class I/II/III medical devices.
Experience with cGMP/QSR, ISO 13485, and Council Directive 93/42/EEC.
Solid organizational, analytical, technical and problem-solving skills.
Ability to work through others.
Strong computer skills and a high attention to detail.
Demonstrated management and leadership skills with the ability to manage a diverse team of individuals (including contractors/consultants).
Experience working in a medium size global company is preferred.
Be able to work in a matrix organization.
Fluent in English, Excellent expression skills - written and verbal.
Responsible, self-motivated, organized and meticulous.
Able to multitask and meet the targets set.
This position is open to all candidates.