Regulatory Affairs Director *Remote*
As the Regulatory Affairs Director, you will provide strategic and operational leadership to direct the planning and execution of the company's regulatory initiatives. You will be responsible for US and OUS regulatory activities, including filing and/or creation of Premarket Notifications, Technical Files, and country-specific product registrations, as required. You will lead cross-functional teams to develop and implement regulatory strategies to ensure the timely introduction of product into the US and OUS markets. You will coordinate and oversee preparation of well?organized, complete and scientifically sound regulatory submissions. If required, you will participate in interactions and discussions with Regulatory Agencies to resolve issues arising during the regulatory submission review process to ensure a timely approval process.
- Lead regulatory strategy formulation to best address corporate priorities; communicate regulatory strategy across the organization
- Provide functional leadership, management and mentoring to the other Regulatory Affairs staff members
- Coordinate and lead efforts associated with the preparation of domestic and international regulatory documents and submission
- Interpret regulatory requirements and changes to ensure all is compliant and information has been distributed through corporate policies and procedures
- Negotiate with regulatory agencies as necessary to expedite approval of product registrations
- Represent Regulatory Affairs on cross-functional project teams
- Review clinical protocols to ensure collection of appropriate data for regulatory submissions
- Review product promotional materials and labeling to ensure compliance
- Participate in internal and external audits
- Analyze product complaints and make recommendations regarding MDR and/or other reportability requirements (as required)
- Support company goals and objectives, policies and procedures, Good Clinical Practices, Good Manufacturing Practices and FDA regulations. Ensure compliance with Quality System Regulations and ISO 13485:2016, EN 46001, and EU MDR requirements.
- Support the RA/ QA team in administering and maintaining key cross-functional quality system functions.
- Serve as PRRC (Person Responsible for Regulatory Compliance).
- 5+ years related experience in a fast-paced medical device, start-up environment
- Bachelor's Degree in a scientific discipline
- Knowledge of US FDA regulations, ISO Standards, and GMPs
- Impeccable attention to detail and organization skills
- International experience and regulatory knowledge with an emphasis in APAC
- Able to provide thorough, practicable, creative but compliant solutions, consistent with organization objectives, to a wide range of regulatory challenges
- Analytical skills
- Ability to sit, stand, and/or walk for no less than 8 hours a day
- Ability to lift a minimum of 25 pounds
- Travel for this position is currently estimated at 10%
- Fully distributed work force
- Company paid medical, dental, and vision insurance
- 401K plan, with company match
- Generous stock options
- Plus, more!