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Associate Regulatory Affairs Specialist
3 months ago
Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.
Get to know us and join our team as
Associate Regulatory Affairs Specialist
Job Function:
Corporate Functions
Location:
El Segundo, CA, US, 90245
Work Flexibility:
Hybrid
KARL STORZ is currently recruiting for an
Associate Regulatory Affairs Specialist
who will be responsible for assisting the US Regulatory Affairs Team in preparing, organizing, and maintaining documentation required for regulatory compliance. This position also assists in communicating product clearance information to other departments within the organization and to external distributors and agencies.
Responsibilities
To be knowledgeable at all times of current and emerging regulatory requirements affecting the business regarding actions necessary to obtain or maintain compliance with applicable regulations.
Report to Senior Manager, Regulatory Affairs on the performance of Regulatory items.
To regularly survey the Regulatory environment, and provide communication and special reports as necessary, to ensure that the company remains aware of significant events or issues which could have a substantial effect (positive or negative) on it.
Maintain high levels of work and accountability.
Help define strategy and provides guidance and support on regulatory requirements to new product development and sustaining projects from initial kick-off to post-marketing phase for US and Canada markets.
Assist and support FDA and Health Canada submissions of simple complexity through to clearance/approvals.
Reviews and approves engineering change orders.
Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management, as required.
Assist in registering products in any other countries as needed.
Prepare briefing documents for and participate in internal regulatory meetings and meetings with regulatory authorities as necessary.
Other incidental duties
Requirements
Bachelor’s degree plus 1-3 years of experience in a highly regulated industry; or 0-1 year of experience with Master’s degree in Regulatory
Excellent problem-solving, organizational, analytical and critical thinking skill
Demonstrates initiative to organizational and process improvements.
Ability to manage multiple projects from start to completion.
Exceptional organizational skills
Strong attention to detail
Ability to manage competing priorities in a fast-paced environment.
Eagerness to learn
Demonstrated experience building strategic partnerships to further departmental and organizational objective.
Ability to travel up to 25%
Preferences
3+ years of experience in a highly regulated industry or within KS organization
Bachelor degree or higher in scientific or engineering field or in regulatory affairs discipline.
Hands on experience using SAP
LI-CW1
Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too*
Up to 8 weeks of 100% paid company parental leave**
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year - Tuition pre-imbursement
Fitness reimbursement of up to $200 annually
Employee referral program of up to $2,000 per hire
And much more
*Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
**To include, maternal/paternal leave, adoption, and fostering of a child.
KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as acondition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to askhow credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
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