Senior Regulatory Affairs Program Lead – Wound Closure & Healing, MedTech Surgery

Job Description:

• Own end-to-end lifecycle maintenance and new product development launches for the Wound Closure and Healing portfolio
• Provide independent regulatory guidance for strategic planning, pre-marketing, and submissions supporting global product launches
• Lead submissions for licenses, authorizations, international registrations, and dossiers for medical devices
• Represent Regulatory Affairs on cross-functional teams and serve as a regulatory subject matter expert
• Define and obtain data supporting regulatory submissions
• Guide regulatory strategy and supporting evidence, including clinical data, for product development and lifecycle change projects
• Prepare expert responses to regulatory agency questions and correspondence
• Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo, and 510(k)s, and EU MDR submissions
• Collaborate on labeling and claims development and approval
• Support internal and external audits
• Plan regulatory deliverables and monitor projects through completion
• Develop Regulatory Affairs process best practices and solve complex problems
• Apply expert knowledge of relevant guidances, regulations, and standards

Requirements:

• Minimum of a Bachelors Degree from accredited college or university is required
• At least 6+ years of regulatory affairs or related/equivalent experience is required; 4+ years with an Advanced Degree
• Experience in healthcare products product industry including submissions is required
• Science, biomedical engineering, medical/scientific writing, or public health administration field of study desired
• Experience with clinical development strongly preferred
• Previous medical device submission experience for medium and high risk devices preferred
• Demonstrated track record of leadership success strongly preferred
• Experience leading multi-functional teams preferred
• Previous experience with combination products preferred
• RAC (Regulatory Affairs Certification) is desirable
• Experience working and negotiating with regulatory bodies is desirable
• Ability to work independently and in a team environment
• Ability to communicate clearly and accurately to a widely varied audience
• Ability to work well under deadlines
• Excellent written and communication skills; fluency in English
• Good judgment/decision-making and problem-solving ability
• Ability to work under own initiative and as a team player
• Remote candidates must be able to travel up to 20%

Benefits:

• Company consolidated retirement plan (pension)
• Savings plan (401(k))
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Remote work options considered on a case-by-case basis
• Up to 20% travel required for remote candidates