Manager/ Director of Regulatory Affairs

　　Summary Description :

　　Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in the creation and maintenance of regulatory files.

　　Experience with the medical device industry:

　　Medical Device Single Audit Program (MDSAP)

　　FDA regulations 21CFR part 820

　　ISO 1345:2016.

　　Health Canada Regulations- SRO 98/282

　　EU MDD and MDR Regulations (EU) 2017/745

　　Quality Management System (QMS)

　　Key Responsibilities :

　　Assurance compliance with applicable medical device regulations per jurisdiction, guidance, and standards

　　Write, analyze, and edit technical documents to support specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents in the USA, Canada, and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.

　　Maintain regulatory files. Maintain and update regulatory authorizations, such as 510(k)s, Canadian medical device licenses, CE Technical Documentation for EU, etc. Assure that appropriate maintenance of registrations occurs, including renewals, device listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required.

　　Assist in preparing responses to regulatory authorities' questions within assigned timelines

　　Assess device-related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities promptly. Handle recalls and field actions, if required.

　　Stay abreast of regulatory procedures and changes in regulatory climate

　　Review product labels and review promotional material for compliance with applicable regulations and technical standards

　　Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.

　　Assist in developing, maintaining, and improving Biolife, LLC’s Quality Management System (QMS)

　　Assist with generations of quality documents: Standard Operating Procedures (SOPs); Work Instructions; Specifications; Master Manufacturing Records; Inspection, Test Procedures, and Report Forms; Equipment Qualifications Protocols; Process Validations Protocols and reports; Design Control documentation; etc.

　　Assist in the review and approval of production records, procedures, and risk assessments

　　Assist with the assessment and closure of nonconformances, corrective actions/preventive actions (CAPAs), deviations, and supplier-initiated change controls

　　Maintain metrics related to the Quality Management System (QMS) in support of the Management Review

　　Create regulatory and QMS awareness and provide training as needed

　　Other duties as assigned

　　Qualifications :

　　10+ years of experience with a bachelor's degree (BS) in the biological sciences or related scientific discipline preferred

　　Regulatory Affairs Certification (RCA) desired

　　Prior experience in Quality Assurance and Regulatory Affairs (QA/RA) in a medical device-regulated industry

　　Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills

　　Excellent written and Verbal communication skills with the ability to listen, articulate, and advocate

　　Proactive, high-performance, result-oriented, and manages projects with ethical integrity

　　Working knowledge of Quality Management System (QMS) and ability to apply GMPs in conformance to U.S., Health Canada, and EU standards

　　Ability to identify compliance risks and escalate when necessary

　　Ability to effectively negotiate and build collaboration among individuals

　　Manage multiple projects and deadlines

　　Demonstrate both creative and critical thinking skills

　　Exceptional organizational skills and attention to detail

　　Knowledge of Microsoft Office (Excel, Word, PowerPoint)

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.