• Establish and drive regulatory strategies for device approvals and provide clear internal communication with key milestone goals for execution of that strategy.
• Maintains compliance with the company quality standards, FDA regulations and guidance, applicable EU Medical Device Directives, applicable ISO standards, and other pertinent country specific medical regulatory requirements.​
• Serve as the Company’s Management Representative per ISO 13485 and during regulatory audits.
• Develops communication plans and drives internal preparation for meetings with regulatory authorities to ensure strong relationships with authority contacts.
• Participates in internal audits, assessments, and Management Reviews of the QMS with suggested changes for continuous improvement.
• Identifies and oversees qualified internal resources, contractors, and consultants to support timely execution of deliverables.
• Authors regulatory submissions such as pre-subs, IDE submissions and de novo / 510(k)s in support of gaining market clearance from regulatory bodies.
• Manages regulatory budget.
• This is not an exhaustive list of duties or functions

Bachelor’s degree in science related field.

• Minimum of 7 years management experience in a medical device or related industry.
• Experience with energy-based medical devices preferred.
• Expertise developing novel or breakthrough Class II or III medical or surgical devices.
• Has in depth knowledge of FDA § part 812, 820; ISO 13485, 14155, 14971 and MDD, and MDR regulations.
• Has excellent attention to detail and documentation practices.
• Ability to read, analyze, and interpret clinical journals and technical reports.
• Has a proven regulatory track record in medical device industry.

• Excellent interpersonal and communication skills.
• Strong leadership skills.
• Excellent ability to multi-task and prioritize.
• Be a self-starter that is comfortable turning high-level direction into a plan that yields results.
• Demonstrated ability to thrive in a high-paced, rapidly changing environment.
• A demonstrated Team Player able to work with an experienced Eximis Surgical team with confidence and professionalism.
• Candidate must have strong desire to be part of a very dynamic and mission driven company.
• Ability to work flexible hours.
• Ability to travel up to 10% Domestic or International.