The Director of Regulatory Affairs drives the company's Regulatory activities, collaborates with technical leadership in the development and manufacturing of breakthrough disposable and reusable medical devices, leads the regulatory strategy, and collaborates in the development and implementation of the company's claim strategy. This position will report to the President/CEO of the company.
Principal Duties and Responsibilities:
- 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 and de novo / 510(k)s in support of gaining market clearance from regulatory bodies.
- Manages regulatory budget.
- Works with clinical study consultants to deliver study results that support FDA submissions and claims strategies.
- This is not an exhaustive list of duties or functions
Knowledge, Skills and Abilities:
- Has 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.
Education/Experience Required:
- 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.
Characteristics:
- 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.
