Regulatory Affairs Specialist IV is responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Affairs Specialist IV requires a bachelor’s degree. Typically reports to a manager or head of a unit/department. To be a Regulatory Affairs Specialist IV typically requires 7+ years of related experience. A specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group.
Regulatory Affairs Specialist IV Job Description Template
Our company is looking for a Regulatory Affairs Specialist IV to join our team.
Responsibilities:
- Manage legalization, Apostille, and notarization process;
- Track and report status of regulatory action items and deliverables to Program Managers and leadership;
- Liaison with external regulatory agencies;
- Provide regulatory oversight in support of design changes;
- Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required;
- Support the manufacturing lines when non-conformance exists to ensure appropriate regulatory assessments and requirements;
- Ensure company complies with the local regulatory requirements of the country in which the product is marketed;
- Regulatory support for external audits (notified body, FDA, health ministries, etc);
- Author premarket submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies;
- Prepare the necessary documentation, and secure necessary approvals;
- Review and collaborate for regulatory assessment of collateral marketing material;
- Respond to regulatory agency inquiries.
Requirements:
- Excellent organizational skills and attention to detail;
- Preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses;
- Applying 21 CFR 803, 806 and 820 regulations;
- Manage changing conditions, processes and approaches; lead organizations through change effectively;
- Experience with medical device development process, design changes and design controls;
- Critical thinker able to address complex situations and issues;
- Experience working with cross-functional product development teams to ensure regulatory compliance;
- Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries;
- Possess an ability to read, understand, and summarize technical and scientific information;
- Acts decisively, holds position and challenges others appropriately;
- Knowledge of EU IVDR regulations;
- Strong work ethic with an ability to work independently;
- Establishing and implementing pre-market regulatory strategy;
- Pragmatic with strong problem-solving skills;
- Successful candidate must have authored at least one (1) 510K.