SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Lead Specialist, Regulatory Affairs - San Diego

Company: Instrumentation Laboratory
Location: San Diego
Posted on: September 17, 2020

Job Description:

Lead Specialist, Regulatory Affairs - San Diego in San Diego, California | Careers at San Diego Skip Branding Select country

Log in

About us

Our Products

Clinical Settings

Support

Continuing Education

Careers

Werfen

Skip to main content Social Links About Us

Careers

Our Products

Support

IL Headquarters 180 Hartwell Road

Bedford, MA 01730 USA

1-800-955-9525

customerservice@ilww.com Legal note

Privacy Policy

Code of Ethics

© Copyright 2018 All Rights Reserved

Lead Specialist, Regulatory Affairs - San Diego in San Diego, California | Careers at San Diego Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Lead Specialist, Regulatory Affairs - San Diego Job Locations US-CA-San Diego Job ID 2020-3614 Type Regular Full-Time Shift 1st Category Regulatory Affairs Overview Instrumentation Laboratory

Our Passion. Your Results.

Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.

Position Summary:

The Lead Specialist, Regulatory Affairs is an experienced individual contributor role responsible for the coordination, and execution of pre and/or post market Regulatory Affairs departmental functions as assigned by management. This role helps to ensure compliance with applicable US and international regulations in which the company does business; preparing product submission documentation for US and international markets, and evaluating product changes for effects on regulatory license registrations.

Responsibilities Key Accountabilities:

Responsibilities may include pre-market and/or post market as defined by the company.

Lead in the preparation and submittal of regulatory information required for market clearance, licensing, registration and legalization

Participate in New Product Development cross-functional teams as the RA core team member

Coordinate, manage, and participate in the development of regulatory strategies and prepare regulatory submissions: US submissions include IDEs, 510(k)s and PMAs, EU submissions include filing and updating Technical Files, and other markets as required

Prepare and maintain US 510(k) and international regulatory submissions, including Regulatory Master Files, Technical Files / Design Dossier documentation as required

Review product change requests and notifications for assessment to regulatory impact to licenses.

Represent Regulatory Affairs on various cross-functional teams: Design Control, Contribute to the development of the project plan and other deliverables.

Represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management and other required documents.

Participate in Design Reviews when appropriate

Review promotional material for compliance to approved indications and supported claims

Author trending reports for pre- and post-market regulatory activities

Expand working knowledge of regulations, standards, company SOPs and tools to keep ahead of changes in the regulatory climate. Integrate these changes in work plans.

Respond to questions from regulatory agencies

Participate in meetings with regulatory agencies (e.g., pre-sub meetings)

Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements.

Monitor external publication sources for issues applicable to Company.

Qualifications Minimum Knowledge & Experience:

Bachelors degree (Science preferred) or equivalent applicable experience strongly preferred

Minimum of four (4) to six (6) years of applicable regulatory affairs (RA) experience, preferably within an in-vitro diagnostics or medical device environment

Must possess demonstrated advanced knowledge of FDA regulations, EU Directives, EU Regulations MDR 2017/745 and IVDR 2017/746 and Canadian medical devices regulations; Must have in-depth experience working with each.

In-depth experience and knowledge regarding global premarket clearance activities strongly preferred

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

Werfen is a global leader in in vitro diagnostics (IVD) in the specialties of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.

We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.

www.instrumentationlaboratory.com/

Options Apply for this job online Apply Share Refer a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Application FAQs Software Powered by iCIMS

www.icims.com

Keywords: Instrumentation Laboratory, San Diego , Lead Specialist, Regulatory Affairs - San Diego, Other , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Hiring CDL A Company Drivers - Home Daily
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: Yucaipa
Posted on: 09/22/2020

Amazon Workforce Staffing: Full-Time Warehouse Team Member - $500 Sign-On Bonus
Description: Earn 15/hr or more, plus benefits and a 500 sign-on bonus. Limited-time opportunity.Shifts: Overnight, Early Morning, Day, Evening, WeekendFull-time jobs available now. Benefits start on your first (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Stylist
Description: Job Description: 10 10 Supercuts - Stylist Are you a stylist with a fun personality, who likes to be financially rewarded for working efficiently, with attention to detail Do you have a passion for (more...)
Company: Supercuts
Location: Yucaipa
Posted on: 09/22/2020


Seasonal Amazon Package Sorter With $250 Sign-on Bonus (San Bernardino)
Description: Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need themSeasonal Warehouse Team MembersShifts: Overnight, Early (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Seasonal Amazon Warehouse Worker With $250 Sign-on Bonus (San Bernardino)
Description: Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need themSeasonal Warehouse Team MembersShifts: Overnight, Early (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Seasonal Amazon Package Sorter with Sign-on Bonus! (San Bernardino)
Description: Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need themSeasonal Warehouse Team MembersShifts: Overnight, Early (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Local CDL A Company Drivers - Southern California, Home Daily!
Description: Hiring Home Daily Company Drivers Our Truck Drivers Enjoy Industry-Leading Benefits: Excellent Pay Based on Experience: Average 1,000- 1,200/week with
Company: Gardner Trucking
Location: Yucaipa
Posted on: 09/22/2020

Amazon Workforce Staffing: Seasonal Part-Time Amazon Package Sorter With $500 Sign-On Bonus
Description: Earn 15/hr or more, plus benefits and a 500 sign-on bonus. Limited-time opportunity.Shifts: Overnight, Early Morning, Day, Evening, WeekendFull-time jobs available now. Benefits start on your first (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Seasonal Amazon Warehouse Operator with Sign-on Bonus! (San Bernardino)
Description: Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need themSeasonal Warehouse Team MembersShifts: Overnight, Early (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Amazon Workforce Staffing: Seasonal Part-Time Amazon Warehouse Worker With $500 Sign-On Bonus
Description: Earn 15/hr or more, plus benefits and a 500 sign-on bonus. Limited-time opportunity.Shifts: Overnight, Early Morning, Day, Evening, WeekendFull-time jobs available now. Benefits start on your first (more...)
Company: Amazon Workforce Staffing
Location: Yucaipa
Posted on: 09/22/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds