Senior Regulatory Affairs Specialist Consultant

Senior Regulatory Affairs Specialist Consultantat ClinChoice (View all jobs)Raritan, New Jersey, United StatesAre 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.POSITION SUMMARYThis 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.Duties/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.Experience/Skills• 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 ProcessOnce 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 ClinChoiceClinChoice 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 EthosOur 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.#LI-PR1