What are the responsibilities and job description for the Regulatory Affairs Specialists position at Aditi Consulting?
Payrate: $39.00 - $43.00/hr.
Responsibilities:
Qualifications:
Desired Skills:
Pay Transparency: The typical base pay for this role across the U.S. is: $39.00 - $43.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy
#AditiConsulting
# 25 - 22934
Responsibilities:
- Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
- Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
- Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
- Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
- Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
- Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
- Contributes to writing and editing technical documents.
- Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
- Ensures compliance with pre- and post-market product approval requirements
- Supports regulatory inspections, as required.
Qualifications:
- Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
- 4 years’ experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
- Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
- Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.
Desired Skills:
- Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. A team player and collaborator.
- Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
- Experience in medical device regulatory affairs
- Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
Pay Transparency: The typical base pay for this role across the U.S. is: $39.00 - $43.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy
#AditiConsulting
# 25 - 22934
Salary : $39 - $43
