Regulatory Affairs Specialist II

YOH Services LLC
401(k), employee discount
United States, California, Irvine
Nov 25, 2024
Regulatory Affairs Specialist II Category: Life Science Employment Type: Contract Reference: BH-372435-1 Regulatory Affairs Specialist II needed for a contract opportunity with Yoh Scientific's client located in Irvine, CA. This position is for a molecular diagnostics manufacturer and the team is looking for candidates with a bachelor's degree along with 3-5 years of experience in RA, QA, R&D, Manufacturing or Project Management. IVD experience is a must. Schedule: M-F, Hybrid, 3 days on-site. 8 am to 5 pm. Responsibilities Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Company products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities. Support the IVDR labeling conversion and revisions of technical files for all the Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation. Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan. Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups, and product restrictions, as required. Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments. Qualifications Requires a bachelor's degree in biochemistry, biology, medical technology or related fields 3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry. Knowledge of FDA, and CE marking requirements for IVD products is a plus. Able to work independently and with others. Communication skills, including negotiation and persuasion. Analytical, problem solving, computer, and critical thinking skills. Thorough knowledge of policies, practices and procedures related to RA. Opportunity is Calling, Apply Now! Contract: 12-month contract with possibility of extension or conversion. Salary: $40 - $45 per hour depending on experience, W2 Recruiter: Ery Baniqued What's In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Medical, Dental & Vision Benefits 401K Retirement Saving Plan Life & Disability Insurance Direct Deposit & weekly ePayroll Employee Discount Programs Referral Bonus Programs Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.