Sr. Regulatory Affairs Specialist in covington, Georgia

Senior Regulatory Affairs Specialist

Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. 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. In addition, this position will help support RA management. This role provides the flexibility to work on-site 4 days weekly in Covington, and remotely Friday on a weekly basis. Key responsibilities will include:

• 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%.

To be successful in this role, you will work independently by applying your written and analytical skills to create technical documents, in some cases to cover design changes and change notifications for BD's wide range of medical devices. You will also leverage your communication skills to work effectively with internal customers and team members as well as external auditors.

Minimum Requirements:

• Education:
  
  Bachelor of Science (BS) degree required, preferably in a scientific discipline, engineering, or other regulated field.
• Experience:
  
  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.
• Technical Knowledge:
  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. Medical device quality systems and regulatory compliance. Preparation and submission of FDA 510(k) premarket notifications. Development and maintenance of technical documentation, including STED/Technical Files. Interactions with regulatory authorities and/or EU Notified Bodies.
• Core Competencies:
  
  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.
• Work Arrangement:
  Ability to work on-site in Covington 4 days per week with remote work on Fridays
• Travel:
  Willingness to travel up to 15% as needed

Preferred Qualifications:

• Education:
  
  BS degree specifically in a Scientific Field (such as Biology, Chemistry, Biomedical Engineering)
• Certification:
  Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS)
• Product Knowledge:
  Familiarity with Class II medical devices, particularly in the urology or acute care hospital setting
• Advanced
  
  Skills:
  
  Experience leading…