Medical Devices / Medical Equipment Position Overview We are seeking an experienced Senior Manager, Regulatory Affairs to lead regulatory strategy and compliance activities for medical device products throughout their development, commercialization, and post-market lifecycle. This role will serve as a key regulatory partner to cross-functional teams and will be responsible for developing regulatory strategies, managing global submissions, interacting with health authorities, and providing regulatory leadership across product programs. Key Responsibilities Develop and implement comprehensive regulatory strategies for new product development, product lifecycle management, and post-market surveillance . Prepare, review, and submit regulatory documentation, including 510(k)s, PMA submissions, Dossiers, Technical Files, CE Mark submissions, and international registrations . Serve as the primary regulatory contact for assigned projects and communicate directly with FDA and other global regulatory authorities during submissions, reviews, and inspections. Interpret and apply applicable regulations, guidance documents, and industry standards to ensure ongoing product compliance. Lead and mentor junior Regulatory Affairs professionals while promoting a strong culture of regulatory compliance and continuous improvement. Participate in internal and external audits and provide regulatory expertise and support. Evaluate the regulatory impact of product changes, manufacturing changes, and quality system changes . Partner closely with R&D, Quality, Clinical, Marketing, Manufacturing, and other cross-functional teams to achieve regulatory objectives. Monitor changes in regulatory requirements, guidance, and industry trends and communicate relevant updates to stakeholders. Lead multiple regulatory projects and ensure submissions and regulatory activities are completed accurately and within established timelines. Required Qualifications Bachelor's degree in a scientific or technical discipline such as Biomedical Engineering, Chemistry, Biology, or a related field. 8-10+ years of Regulatory Affairs experience within the medical device industry . At least 3-5 years of experience in a senior-level or leadership role . Demonstrated experience preparing and submitting regulatory applications, including: FDA 510(k) PMA CE Mark International regulatory registrations Strong working knowledge of: FDA regulations / 21 CFR
ISO 13485 EU
Medical Device Regulation (EU MDR) International medical device regulatory requirements Proven experience developing regulatory strategies across the product development and product lifecycle . Strong leadership, project management, communication, and problem-solving skills. Ability to manage multiple priorities in a fast-paced, cross-functional environment. Strong written and verbal communication skills with the ability to explain complex regulatory requirements to technical and non-technical stakeholders. Experience with regulatory information management systems and tools . Preferred Qualifications Master's degree or PhD in a relevant scientific or technical discipline. RAC (Regulatory Affairs Certification) . Experience working directly with FDA and international health authorities. Experience supporting regulatory inspections, audits, and post-market activities. Work Location This is an onsite position in Covington, Georgia , with the flexibility to work from home on Fridays .
