Job Description

Senior Regulatory Affairs Specialist Consultant Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Regulatory Affairs Specialist Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Summary This position is open to candidates who have a minimum of 5 years of hands-on regulatory experience with US and EU Class III medical devices focusing on regulatory submissions and other relevant activities such as change assessments. This position requires a strong team player who can work across various cultures and departments to meet team, company, and client goals and assigned objectives. Main Job Tasks and Responsibilities:

• Provide regulatory input and guidance during New Product Development and Lifecycle Management projects, including Regulatory strategy and supporting evidence including clinical data.
• Provide Regulatory assessments for new products and manufacturing/product changes (e.g. change orders)
• Define data and information needed for regulatory approvals of Class III US/EU medical devices and high-risk ROW.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines; Prepare and submit regulatory submissions to FDA (e.g., 30-day notices, 135-Day Supplements, etc.,) and Notified Body (e.g. TD).
• Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed.
• Prepare responses to Regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals.
• Provide Regulatory input and guidance to cross-functional teams.
• Partner with RA affiliates on submission pathways in their respective country as well as other functions to define and obtain data to assist with regulatory submissions.
• Review and assess Clinical reports as needed.
• Represent Regulatory Affairs and provide regulatory advice on cross-functional project teams.
• Plan schedules for regulatory deliverables on a project and monitor project through completion.
• Collaborate in the development and approval of labeling, after evaluating conformance to regulations. Review marketing material as needed.
• Guide conformance with applicable regulations in product development, support of claims and label content.
• Maintain various tracking tools to ensure up to date information and traceability of all regulatory data/documentation.
• Provide solutions to complex problems where analysis of situations or data requires an in-depth evaluation of multiple variables.
• Effectively communicate with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectation.
• Perform other duties assigned as needed.

Education and Experience:

• Minimum of 5 years of hands-on regulatory experience with US and EU Class III medical devices focusing on regulatory submissions and other relevant activities such as change assessments.
• Must have proven ability to prepare and submit Class III medical device submissions to FDA and Notified Body including assessments and submittal of product changes.
• Experience with FDA PMA regulations, EU MDD/MDR, ISO13485 and ISO14971.
• Experience in working with cross-functional teams on product development and manufacturing projects.
• Must possess excellent written and verbal communication skills.
• Proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint).
• Good understanding of current Good Documentation Practices in regulatory environment.
• Strong organizational skills including attention to detail, good planning and communication skills are required.
• Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation. or data requires evaluation of various factors with minimal supervision.
• Detail oriented with strong critical thinking and analytical skills and keen on producing results.

The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Are you legally authorized to work in the country that you are being hired? * If "yes", will you now or in the future require sponsorship to work in the country that you are being hired? * What type of employment are you seeking? * Permanent Subcontractor Intern Temporary Area of expertise - Therapeutic area or other skills Have you previously worked for ClinChoice or its subsidiaries? If yes, please provide additional details Do you have a friend or family member working for ClinChoice? If yes, please provide additional details. Are you currently employed? * Current Address Date available to work? * Employment History: Please list your two most recent employers, including name of the company, job title, and dates employed * Are you willing to undergo a background check upon employment? * If hired, can you furnish proof you are eligible to work in the country you are being hired? * How did you hear about this opening? * Will you relocate if the job requires it? * How much are you willing to travel? * Are you ok to work in a hybrid model work schedule? * What is your desired salary/hourly rate? * Please read and accept our privacy policy: * I certify all information provided in this employment application is true and complete. I understand any false information or omission may disqualify me from further consideration for employment and may result in my dismissal if discovered at a later date. I authorize the investigation of any or all statements contained in this application and also authorize any person, school, current employer (except as previously noted), past employers and organizations’ names in this application to provide relevant information and opinions that may be useful in making a hiring decision. I release such persons and organizations from any legal liability in making such statements. I understand if I am extended an offer of employment, it may be contingent upon my successfully passing a complete background and reference check. I hereby consent to any or all of these pre-employment test/screen/checks as a condition of employment, if required. I consent to the release of any or all medical information as may be deemed necessary to judge my capability to do the work for which I am applying. I UNDERSTAND THIS APPLICATION OR SUBSEQUENT EMPLOYMENT DOES NOT CREATE A CONTRACT OF EMPLOYMENT NOR GUARANTEE EMPLOYMENT FOR ANY DEFINITE PERIOD OF TIME. IF EMPLOYED, I UNDERSTAND THAT I HAVE BEEN HIRED AT THE WILL OF THE EMPLOYER AND MY EMPLOYMENT MAY BE TERMINATED AT ANY TIME WITH OR WITHOUT CAUSE AND WITH OR WITHOUT NOTICE. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in ClinChoice’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in ClinChoice’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. Gender Are you Hispanic/Latino? Please identify your race Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? 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Hourly pay, Permanent employment, Contract work, Temporary work, For contractors, For subcontractor, Relocation, Visa sponsorship,

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