The Senior Regulatory Affairs Specialist will complete regulatory activities to support currently marketed devices and new product development in the within the Vision Care portfolio with an emphasis on combination products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.
- Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and timelines.
- Define, gather and assemble information needed for submissions according to applicable regulations and relevant guidelines
- Lead or support the submission of licenses and authorizations for new products and changes to existing products
- Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals
- Provide Regulatory Affairs support during internal and external audits
- Plan schedules for project regulatory deliverables and monitors through completion
- Assists in the development of standard process for Regulatory Affairs processes and systems
Education and Qualifications
- A minimum of a Bachelor’s degree is required. A concentration in science, engineering, medical/scientific writing, public health administration is preferred.
- Minimum 4 years of working experience within Regulatory Affairs or equivalent.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything