Sr. Regulatory Affairs Specialist

About the Role

Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, along with supporting all other geographical regions registrations. This role provides the flexibility to work on-site 4 days weekly in Covington, and remotely Friday on a weekly basis.

Responsibilities

• Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents).
• Prepare &/or revise STED technical files for CE marking activities and notified body interaction to support EU/MDR product maintenance, as required.
• Provide support and guidance for post market activities including remedial actions, labeling.
• Prepare and support 510(k) &/or change assessments, as required.

Limited travel required – 15%.

Requirements

• Bachelor of Science (BS) degree required, preferably in a scientific discipline, engineering, or other regulated field.
• Minimum 4 years of Regulatory Affairs experience within the medical device industry.
• Experience supporting product registration, regulatory compliance, and quality system activities for medical devices.
• Working knowledge of U.S. FDA regulations, including 21 CFR Part 820, and European Medical Device Regulation (EU MDR).
• Experience with U.S., EU, and international product registration activities.
• Experience with medical device quality systems and regulatory compliance.
• Experience with preparation and submission of FDA 510(k) premarket notifications.
• Experience with development and maintenance of technical documentation, including STED/Technical Files.
• Experience with interactions with regulatory authorities and/or EU Notified Bodies.

Skills

• Demonstrated ability to support products throughout the product lifecycle, including product development, design changes, and post-market activities.
• Experience developing regulatory strategies, conducting change assessments, and managing regulatory deliverables and timelines.
• Strong technical writing skills with the ability to prepare clear, accurate, and compliant regulatory submissions.
• Ability to maintain confidentiality when handling regulatory, clinical, and business-sensitive documentation.
• Strong organizational and project management skills with the ability to prioritize multiple projects and meet deadlines.
• Self-motivated with the ability to work independently, exercise sound judgment, and take ownership of responsibilities.
• Effective written and verbal communication skills with demonstrated success working on cross-functional teams.

Preferred Qualifications

• BS degree specifically in a Scientific Field (such as Biology, Chemistry, Biomedical Engineering).
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
• Familiarity with Class II medical devices, particularly in the urology or acute care hospital setting.
• Experience leading regulatory activities on cross-functional product development teams.
• Ability to influence project teams and communicate regulatory risks and mitigation strategies.
• Strong analytical skills for evaluating technical data and determining regulatory impact.
• Excellent communication skills for interactions with regulatory authorities, Notified Bodies, auditors, and cross-functional stakeholders.

Schedule

• Ability to work on-site in Covington 4 days per week with remote work on Fridays.
• Willingness to travel up to 15% as needed.

Location

USA GA - Covington

Primary work shift: US BD 1st Shift 8am-4:30pm