Regulatory Affairs Associate

As a Regulatory Affairs Associate at ClinChoice, you will handle various responsibilities essential for global regulatory product registrations and submissions. You will manage the preparation of documents and applications for regulatory approvals, including medical device applications, ensuring compliance with regulations like ISO 13485 and CE marking. This involves close communication across teams and departments to meet project objectives effectively.

Candidates applying for the Regulatory Affairs Associate role at ClinChoice should possess a Bachelor’s or Master’s Degree in Science, Medicine, Pharmacology, Medical Engineering, or equivalent education. Familiarity with regulatory frameworks and standards, such as the MDR and ISO 13485, is preferred. Additionally, strong organizational skills and attention to detail are crucial for success in this position.

While prior regulatory experience is not mandatory for the Regulatory Affairs Associate role at ClinChoice, a basic understanding of medical device regulations is beneficial. The position is open to recent graduates eager to learn and grow in the regulatory field, making it an excellent opportunity for entry-level candidates.

At ClinChoice, the work environment promotes collaboration and teamwork. As a hybrid position, you will spend part of your week onsite in Cincinnati, Ohio, allowing for dynamic interactions with team members and clients. Our company culture emphasizes support, development, diversity, and inclusivity, which fosters a positive atmosphere for both personal and professional growth.

Success as a Regulatory Affairs Associate at ClinChoice hinges on strong organizational skills, attention to detail, and excellent verbal and written communication abilities. Being a self-starter who can work effectively within teams and manage multiple tasks will also contribute to your effectiveness in this role.

Certainly! The regulatory process in medical devices involves multiple stages, including product development, premarket submissions, and ongoing compliance post-market. Understanding regulations such as ISO 13485 or the MDR is essential. Be prepared to discuss how you would ensure compliance throughout each stage.

I prioritize tasks based on deadlines and the complexity of each submission. I use a tracking system to ensure all documents are organized and up to date. Effective communication with team members is also crucial to ensure we meet all necessary timelines.

I am proficient in Microsoft Office Suite, especially Word and Excel, which are essential for preparing regulatory documents. Familiarity with document management systems and tracking tools is also advantageous for maintaining compliance documentation.

While I haven't faced direct compliance issues personally, in my academic projects, I analyzed case studies where compliance was violated and explored the resolution steps taken. I would approach a compliance issue by thoroughly investigating the matter, communicating with stakeholders, and coordinating corrective measures as required.

I believe in clear, open communication and establishing roles within the team based on individual strengths. Regular check-ins and updates help ensure everyone is aligned, and I would proactively assist teammates to facilitate timely submissions.

I actively follow various regulatory agency websites, subscribe to industry newsletters, and participate in webinars or workshops relevant to regulatory affairs. Networking with professionals in the field also provides valuable insights into upcoming changes.

During my studies, I juggled multiple research projects and assignments. I set up a detailed timeline for each task and prioritized based on urgency while ensuring quality was maintained across all projects. I find a systematic approach helps with time management and reduces stress.

I'm drawn to ClinChoice because of its commitment to innovation and improving global health outcomes. The opportunity to contribute to impactful projects while working in a supportive and collaborative environment aligns perfectly with my career goals in regulatory affairs.

I view feedback as an essential opportunity for growth. I appreciate constructive criticism and take it to heart, using it to improve my skills and work processes. I believe open dialogue fosters a healthy work environment.

I am detail-oriented, organized, and passionate about contributing to healthcare. My academic background has provided me with a strong foundation in regulatory compliance, while my collaborative nature allows me to work effectively within diverse teams.