Senior Regulatory Affairs Manager
Company: Nihon Kohden
Location: Irvine
Posted on: February 18, 2021
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Job Description:
The Senior--Regulatory Affairs Manager is responsible for
developing and influencing regulatory policy and determining--and
pursuing courses of action necessary to obtain regulatory approval
for the organization's products. Working--closely with all
departments to develop and execute clinical strategies. Successful
execution of clinical studies--from initial strategy and
development to study closeout, meeting all budget considerations
and regulatory--compliance. Sets strategy for worldwide
governmental approval to introduce new products to market,
provides--advice on regulatory requirements and prepares worldwide
submissions. ESSENTIAL FUNCTIONS AND BASIC DUTIES
--- Prepare worldwide submissions for new products and product
changes as required to ensure timely--approval for clinical studies
and market release. Review significant regulatory strategies with
leadership--team, as necessary, and negotiate submission steps with
regulatory bodies.
--- Prepare regulatory strategies/plans and worldwide requirements
lists. Provide on-going support to core--and project teams for
regulatory issues and questions. Find, interpret, and apply
regulations and--guidance appropriately for situations.
--- Provide business and product information to Sr. Director of
Quality and Regulatory Affairs to enable--development or strategies
and requirements and communicate information to leadership
team.
--- Provide regulatory support for currently marketed products, as
necessary. This includes reviewing--labeling, promotional
materials, changes to existing devices and documentation. Prepare
submissions--and reports for regulatory agencies as required.
--- Negotiate directly with the FDA or other international
agencies, as needed. All significant changes will--be reviewed with
the Sr. Director of Quality and Regulatory Affairs.
--- Maintain Regulatory Affairs product files to support compliance
with regulatory requirements.
--- Interact frequently with different members of the organization
and outside customers.
--- Keeps current on global directives, harmonized standards and
procedures and communicates changes--that may affect cross
functional areas.
--- Review training, promotional and advertising pieces for
assigned product lines.
--- Provide training and support to other members of the
department.
--- Manage FDA Establishment Registrations and Listings.
--- Support Quality Systems Projects as required.
--- Development and implementation of regulatory and clinical
strategies, working closely with marketing and--regulatory and
clinical project teams.
--- Overall execution of the company's clinical programs.
--- Leadership of internal clinical project team.
--- Recruitment and management of contracted clinical support such
as consultants, CRO's, data--management.
--- Assistance in the development of all clinical protocols,
agreements & budgets, and related study--documents.
--- Oversight of clinical investigator and site selection.
--- Coordination and tracking of all IRB submissions and
correspondence.
--- Development and maintenance of study trial master files
(TMF).
--- Preparation of regulatory submissions, (510(k)s, IDE's, related
FDA Correspondence), including the--review of content, assembly,
and sign-off approval of final documents.
--- Assistance to the regulatory guidance regarding product
labeling, marketing materials and social media.
--- Adheres to all company policies, procedures, and business
ethics codes.
--- Other duties as assigned. QUALIFICATIONS
EDUCATION/CERTIFICATION:--Bachelor's Degree required, preferably in
Science or Engineering field. REQUIRED KNOWLEDGE:
--- Preferred experience in medical device and software
industry
--- Ability to provide solutions to a wide range of difficult
problems. Solutions are imaginative, thorough, practical,--and
consistent with organizational objectives
--- Strong problem-solving skills. Ability to analyze a wide range
of information, including conflicting and--ambiguous inputs and
propose solutions
--- Strong organizational, time management and project management
skills
--- Clinical, Quality or Regulatory compliance experience
--- Complete understanding and wide application of technical or
regulatory principles, theories and concepts;--general knowledge of
other related disciplines
--- Demonstrated ability to independently assess risk and develop
solutions to critical and difficult problems that--are consistent
with organizational objectives
--- Can conduct full range of data collection duties, including
equipment setup and operations, execution of study--per procedures,
collect data, verify results and transfer data back to NKA,
etc.
--- Plan, implement and conclude clinical studies in support of
project timelines/market release goals with--minimal supervision;
An advanced individual may conduct more complicated studies, as
well as contributes to--study proposals and protocols, applying
principles of clinical study design and research methodology
to--assigned research projects
--- Prepares and documents study plans, contracts, budgets,
informed consents, IRB submissions, case report--forms (CRFs), and
other study related materials to assure quality, consistency,
compliance, organization,--storage and accuracy across all assigned
projects
--- Contribute to clinical study design, proposals, protocols,
etc., understanding basic scientific content,--experimental design,
and analytical approaches used
--- Can effectively work and communicate with investigator, staff
and patients in professional, sensitive and--mature manner
--- Conduct site monitoring (qualification, initiation, monitoring
and close out visits) to insure and document site is--trained to
follow study procedures per protocol;
--- Likewise, can monitor safety reviews and adverse event
reporting for investigational medical devices to--assure adherence
to Good Clinical Practices (GCP), FDA and MDD regulations
--- Can suggest improvements to departmental procedures relating to
GCP monitoring aspects
--- Insure essential study documents are properly organized and
stored as quality records
--- Can conduct basic data analysis using spreadsheets, preparing
basic calculations, statistics, graphs and--tables
--- Writes clear, succinct and detailed clinical study and
technical summary reports EXPERIENCE REQUIRED:--Minimum of 8 years'
experience SKILLS/ABILITIES:
--- Effective presentation and interpersonal skills
--- Self- motivation
--- Excellent verbal/written communication skills
--- Project Management and problem-solving skills
--- Strong attention to detail and accuracy
--- Ability to communicate persuasively in a manner that supports
approvals and other key company--goals/objectives EEO Policy
Statement It is the policy of Nihon Kohden America not to
discriminate against any employee or applicant for employment
because of race, color, religion, sex, sexual orientation, gender
identity, national origin, age, marital status, genetic
information, disability or because he or she is a protected
veteran. It is also the policy of Nihon Kohden America to take
affirmative action to employ and to advance in employment, all
persons regardless of race, color, religion, sex, sexual
orientation, gender identity, national origin, age, marital status,
genetic information, disability or protected veteran status, and to
base all employment decisions only on valid job requirements. This
policy shall apply to all employment actions, including but not
limited to recruitment, hiring, upgrading, promotion, transfer,
demotion, layoff, recall, termination, rates of pay or other forms
of compensation and selection for training, including
apprenticeship, at all levels of employment. Employees and
applicants of Nihon Kohden America will not be subject to
harassment on the basis of race, color, religion, sex, sexual
orientation, gender identity, national origin, age, marital status,
genetic information, disability, or because he or she is a
protected veteran. Additionally, retaliation, including
intimidation, threats, or coercion, because an employee or
applicant has objected to discrimination, engaged or may engage in
filing a complaint, assisted in a review, investigation, or hearing
or have otherwise sought to obtain their legal rights under any
Federal, State, or local EEO law is prohibited. As CFO of Nihon
Kohden America, I am committed to the principles of Affirmative
Action and Equal Employment Opportunity. In order to ensure
dissemination and implementation of Equal Employment Opportunity
and affirmative action throughout all levels of the company, I have
selected Melanie Nguyen, Human Resources Representative, as the
Equal Employment Opportunity (EEO) Manager for Nihon Kohden
America. One of the EEO Manager's duties will be to establish and
maintain internal audit and reporting systems to allow for
effective measurement of Nihon Kohden America's programs. In
furtherance of its policy regarding Affirmative Action and Equal
Employment Opportunity, Nihon Kohden America has developed a
written Affirmative Action Program which sets forth the policies,
practices and procedures that Nihon Kohden America is committed to
in order to ensure that its policy of nondiscrimination and
affirmative action is accomplished. This Affirmative Action Program
is available in the Human Resources office for inspection by any
employee or applicant for employment upon request, during normal
business hours.-- We request the support of all employees in
accomplishing Equal Employment Opportunity.
Keywords: Nihon Kohden, Irvine , Senior Regulatory Affairs Manager, Executive , Irvine, California
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