Regulatory Affairs Officer

DESCRIPTION OF JOB DUTIES

- Monitor and report status of MMD projects regarding progress against task order milestones, sponsor objectives, resource utilization and budgets;
- Oversee the execution of EU vigilance and field safety corrective actions;
- Oversee the execution of EU device and authorized representative registrations;
- Establish and maintain ongoing Sponsor relationships by serving as primary contact for Sponsor and internal project team members;
- Interact with appropriate national/regional regulatory agencies;
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
- Provide regulatory advice and guidance to internal and external teams to ensure compliance with appropriate national/regional regulations and requirements;
- Present during bid defenses, general capabilities meetings, and audits;
- Identify areas of improvement to project management processes and documentation, and implement changes as necessary; and
- Develop and mentor employees and serve as resource for all MMD staff.

QUALIFICATIONS/REQUIREMENTS

- Bachelor's degree in Life Sciences or related field;
- Minimum of 5-7 years working in the medical device industry with progressively more responsibility;
- Well-developed team player experience and skills, operating with a global mindset;
- Excellent verbal and written communication, influencing and interfacing skills;
- Documented knowledge of regulatory/quality system requirements for medical devices (EU, FDA, ISO etc.);
- Effective report, business correspondence, and procedure-writing skills;
- Effective process development and project management skills;
- Good problem identification, analysis and solving skills;
- Capable of multi-tasking and handling tasks with competing priorities effectively