-
Associate Regulatory Affairs Specialist
1 week ago
Karl Storz GmbH & Co. KG El Segundo, United StatesKARL 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 communi ...
-
Associate Regulatory Affairs Specialist
2 weeks ago
KARL STORZ Endoscopy - America El Segundo, United StatesJob Description · 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 ...
-
Associate Regulatory Affairs Specialist
2 weeks ago
Karl Storz Endoscopy-America El Segundo, United StatesKARL 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 communi ...
-
Public Affairs Engagement Specialist
2 weeks ago
Los Angeles Times El Segundo, United States Part timeJoin the hundreds of talented and innovative team members who are making an impact every day at California Times, incorporating Los Angeles Times. Whether you love to tell compelling stories or want to drive our award-winning powerhouse in new directions, the Los Angeles Times te ...
-
Regulatory Affairs Specialist
1 week ago
PureTek Corp Los Angeles, United StatesJob Description · Job Description PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well-be ...
-
Regulatory Affairs Specialist
1 week ago
Curtis Food Recruiters Los Angeles, United StatesSimply Good Foods is seeking a Regulatory Affairs Specialist to support continued growth. This is a critical role for the organization, supporting the Quest and Atkins brands in complying with regulations and laws at the ingredient and trade levels. · Keys to success in this rol ...
-
Regulatory Affairs Specialist
1 week ago
PureTek Los Angeles, United StatesJob Description · Job Description · PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well ...
-
Regulatory Affairs Specialist
1 week ago
SprintRay Inc. Los Angeles, United StatesLocation: On-Site · At SprintRay, we are in a super-charged growth mode and are constantly looking for ways to maintain the quality of our products and processes while growing at a phenomenal pace. To help grow and maintain the regulatory and quality standards, we are seeking a ...
-
Regulatory Affairs Specialist
1 week ago
BioPhase Solutions Los Angeles, United StatesJob Description · Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Regulatory Affairs Specialist to work for a leading Greater Los Angeles area medical device comp ...
-
Regulatory Affairs Specialist
3 weeks ago
Curtis Food Recruiters Los Angeles, United StatesSimply Good Foods is seeking a Regulatory Affairs Specialist to support continued growth. This is a critical role for the organization, supporting the Quest and Atkins brands in complying with regulations and laws at the ingredient and trade levels. · Keys to success in this rol ...
-
Regulatory Affairs Specialist
3 weeks ago
Kindeva Drug Delivery Los Angeles, United States19901 Nordhoff St, Northridge, CA 91324, USA · Req #981 · 04 April 2024 · K indeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our custome ...
-
Regulatory Affairs Specialist
2 weeks ago
Kindeva Drug Delivery Los Angeles, United States19901 Nordhoff St, Northridge, CA 91324, USA Req #98104 April 2024K indeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to imp ...
-
Regulatory Affairs Specialist
2 weeks ago
The Simply Good Foods Company Thousand Oaks, United StatesAre you a detail-oriented professional with a passion for regulatory compliance? Do you excel in ensuring products meet the highest standards? If so, Simply Good Foods is looking for youAs a Regulatory Affairs Specialist, you will be a key player in our R&D team, ensuring our Que ...
-
Regulatory Affairs Specialist
2 weeks ago
Kindeva Drug Delivery Northridge, United StatesKindeva Drug Delivery · Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. To ...
-
Sr. Regulatory Affairs Specialist
1 week ago
Cypress HCM Los Angeles, United StatesSr. Regulatory Affairs Specialist · Location: Los Angeles, Ca · Company Size: 200/ Team Size: 15 · Duties & Responsibilities: · Manage all regulatory activities necessary to maintain and to grow the business. · Develop and implement regulatory strategies for new and existing pro ...
-
Regulatory Affairs Specialist
1 week ago
Medtronic, plc Northridge, United StatesYou will primarily focus on developing and refining fit-for-purpose regulatory strategies to support the digital health innovations of the Diabetes business in early phases of development with stakeholders across the business - US, EU, international Cybersecurity, Regulatory, Sec ...
-
Entravision Communications Santa Monica, United StatesJob Description · Job DescriptionCommunity Engagement and Government Affairs Specialist · Santa Monica, CA | Full Time · *Interested candidates must apply on Entravision's career site: · Summary · As a Community Engagement and Government Affairs Specialist at Entravision Communic ...
-
Principal Regulatory Affairs Specialist
6 days ago
Medtronic Los Angeles, United StatesCareers that Change Lives · Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than ...
-
Principal Regulatory Affairs Specialist
1 week ago
Medtronic Los Angeles, United StatesCareers that Change LivesTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than ye ...
-
Sr. Regulatory Affairs Specialist
2 weeks ago
Cypress Human Capital Management, LLC Los Angeles, United StatesSr. Regulatory Affairs Specialist · Location: · Los Angeles, Ca · Company Size : 200/ · Team Size : 15 · Duties & Responsibilities: · Manage all regulatory activities necessary to maintain and to grow the business. · Develop and implement regulatory strategies for new and exist ...
Associate Regulatory Affairs Specialist - El Segundo, United States - KARL STORZ SE & Co. KG
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Every day our products and services help to save livesaround 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.
ResponsibilitiesTo 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.
#J-18808-Ljbffr