About this role
Role Description
The Regulatory Affairs Consultant II collaborates with cross-functional teams to support medical device product changes and secure regulatory approvals or clearances, as applicable. In this role, the individual will contribute to a Regulatory Affairs team responsible for supporting one or more regulatory functions across client projects, with responsibilities tailored to their experience, expertise, and professional development opportunities.
What You'll Do
- Provide regulatory support for device systems and associated 510(k) activities
- Primary focus will be on change assessment activities for commercially released devices in the sustaining phase of the product lifecycle
- Conduct day-to-day change assessments and support Letters to File (LTFs)
- Prepare and coordinate activities for 510k submissions for medical devices
- Support multiple devices and ongoing product maintenance initiatives
- Represent regulatory function on cross-functional product development and manufacturing support teams
- Guide teams to provide content for US and/or International submissions, participates in design reviews as needed
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects
- Support Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling
- Responsible for FDA/ISO/EUMDR compliance documentation
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Interact with country regulatory teams as needed
- Assist in special projects as needed
- Contribute to team effort by accomplishing related duties as requested
Qualifications
- A minimum of five years of directly related experience in Regulatory Affairs in the medical device industry
- Demonstrated ability to select, organize, lead, participate, and facilitate a team to produce results
- Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment
- Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills
- Demonstrated proficiency in regulatory planning and strategy (510(k)/IDE/PMA) submissions along with strong negotiation skills
- Ability to represent Regulatory Affairs to other departments
- RAC certification highly desirable
- Experience with EU MDR is not required but would be considered a plus
Company Description
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.