Regulatory Relations Specialist jobs in Carlsbad, CA

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)

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Regulatory Affairs Specialist
  • Argen Corporation
  • San Diego, CA FULL_TIME
  • Regulatory Affairs Specialist

    Monday – Friday, 8:30 am – 5:00 pm

    About Us

    At Argen, we’re in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. We are 500 team members strong. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with a product offering that spans fixed, removable, ortho, implants, and equipment. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen’s products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed.


    About the Opportunity 

    The Regulatory Affairs Specialist is responsible for ensuring foreign and domestic compliance for regulated dental products adhering to Quality and Regulatory compliance. This role works in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licensing, registrations and inspections in compliance with local, state, national and international regulatory requirements.


    In this role, the successful candidate will: 

        Maintains Regulatory Affairs certifications for domestic and international customers and distributors.

        Ensures Argen uses relevant information and judgement to determine whether events or processes comply with laws, regulations, or standards.

        Reviews document changes, product labeling and in-house procedures to ensure regulatory requirements are met.

        Prepares for and facilitates internal, external, and third-party audits as necessary.

        Provides input for selecting the most effective regulatory course of action.

        Supports International Operations with foreign product registration through distributors according to each country’s regulatory requirements.

        Researches and responds to internal and external customer requests for regulatory information.

        Interprets regulatory rules or rule changes and ensures that they are communicated through corporate policies and procedures.

        Interfaces with the FDA concerning issuing Certificates to Foreign Government for The Argen Corporation and its subsidiaries as needed.

        Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for The Argen Corporation and its subsidiaries interfacing with Notified Bodies.

        Maintains Declaration of Conformities for all Argen products and its subsidiaries.

        Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

        Accurately maintains the regulatory database to reflect all current and obsolete products.

        Communicates with the Secretary of State office, Department of State and Foreign Embassies or Consulates regarding authentication of documents to support the registration process.

        Supports product registration for Argen’s International Branches to meet foreign requirements for China, Canada, Taiwan, Korea, and others.

        Develops and generates customer-specific certificates of quality analysis and conformities to satisfy distributor and customer-specific needs.

        Completes supplier and subcontractor evaluations and approval forms for customers.

        Provides and submits regulatory documentation to notified bodies and Authorized Representative to support MDD/MDR requirements.

        Represents Regulatory Affairs and Quality team in yearly audits for quality and regulatory documentation including Technical Documentation.

        Contributes to Regulatory projects and deliverables to ensure Argen remains compliant to MDR and ISO requirements.

        Other duties as assigned.


    What does it take to be successful?

        Bachelor’s degree and 5 years of progressive experience in quality assurance and regulatory experience, or equivalent combination of education and experience.

        Experience in the medical device industry preferred.

        Ability to comprehend and follow technical work instructions and standard operating procedures. 

        Working knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred

        Strong problem solving, administrative, and data management skills.

        Demonstrated attention to detail.

        Team player with ability to work independently.

        Ability to multi-task, work under pressure and meet deadlines.

        Strong written and verbal communication skills.

        Maintain certification for California Notary Public. 


    Our Awesome Benefits!

    Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes:

        Health Plans

        Dental Plans

        Vision Plan

        401k with Employer Match

        Paid Time Off and Paid Holidays

        Employee Events

        Wellness Programs

        Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!


    EOE/M/F/Vet/Disabled VEVRAA Federal Contractor


  • 20 Days Ago

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Principal Regulatory Affairs Specialist
  • Tandem Diabetes Care
  • San Diego, CA FULL_TIME
  • GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for ...
  • Just Posted

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Regulatory Compliance Specialist
  • Imperial Irrigation District
  • Imperial, CA FULL_TIME
  • Under general supervision, directs and monitors regulatory compliance activities associated with district operations; provides regulatory compliance services for district operations by developing, pla...
  • Just Posted

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Government Regulatory Compliance Specialist
  • General Atomics Aeronautical Systems
  • Poway, CA FULL_TIME
  • General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as adv...
  • 1 Day Ago

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Regulatory Affairs Specialist
  • Alphatec Spine
  • Carlsbad, CA FULL_TIME
  • ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of s...
  • 1 Day Ago

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Sr. Specialist, Regulatory Affairs
  • Alphatec Spine
  • Carlsbad, CA FULL_TIME
  • The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the...
  • 14 Days Ago

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0 Regulatory Relations Specialist jobs found in Carlsbad, CA area

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ED CASE MANAGER (RN/LIC) - Full Time - Currently 8 hour possibility of becoming 12 hour
  • UHS
  • Murrieta, CA
  • Responsibilities Southwest Healthcare Inland Valley Hospital in Wildomar, California , is a licensed 122-bed facility ac...
  • 3/28/2024 12:00:00 AM

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Registered Nurse (RN) - Med/Surg/Tele Float Pool - Full Time Nights
  • Universal Health Services
  • Wildomar, CA
  • Responsibilities Tired of the same ol' day to day? Come join our Float Pool and see where the day takes you! Sign on Bon...
  • 3/28/2024 12:00:00 AM

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Registered Nurse (RN) - Med/Surg/Tele - Full Time Nights
  • UHS
  • Wildomar, CA
  • Responsibilities Southwest Healthcare Inland Valley Hospital in Wildomar, California, is a licensed 122-bed facility acc...
  • 3/28/2024 12:00:00 AM

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Executive Director, Safety & Pharmacovigilance (PV)
  • Ionis Pharmaceuticals Inc.
  • Carlsbad, CA
  • Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin...
  • 3/28/2024 12:00:00 AM

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Customer Solutions Specialist
  • Alphatec Spine
  • Carlsbad, CA
  • The Customer Solutions Representative is responsible for providing quality service in all areas relative to serving the ...
  • 3/28/2024 12:00:00 AM

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Registered Nurse (RN) - PCU - Per Diem Day Shift
  • Universal Health Services
  • Wildomar, CA
  • Responsibilities Southwest Healthcare Inland Valley Hospital in Wildomar, California, is a licensed 122-bed facility acc...
  • 3/27/2024 12:00:00 AM

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Senior Regulatory Affairs Specialist
  • Planet Pharma
  • Temecula, CA
  • Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs Education: BA Degree Required ...
  • 3/25/2024 12:00:00 AM

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Principal Regulatory Affairs Specialist-Coronary Vascular
  • Philips
  • San Diego, CA
  • Job Title Principal Regulatory Affairs Specialist-Coronary Vascular Job Description The Principal Regulatory Affairs Spe...
  • 3/25/2024 12:00:00 AM

Carlsbad is a city in North County, San Diego County, California, United States. The city is 87 miles (140 km) south of Los Angeles and 35 miles (56 km) north of downtown San Diego and is part of the San Diego-Carlsbad, CA Metropolitan Statistical Area. Referred to as "The Village by the Sea" by locals, Carlsbad is a tourist destination. The city's estimated 2014 population was 112,299. Among the nation's top 20 wealthiest communities, Carlsbad is the 5th richest city in the state of California with a median household income close to US$105,000. According to the United States Census Bureau, t...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$79,661 to $109,360
Carlsbad, California area prices
were up 2.6% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020