SUMMARY OF POSITION:
The Regulatory Affairs Manager will have the responsibility for managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This position will function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. This person will develop appropriate responses to FDA 483s and Warning letters.
POSITION SUCCESS FACTORS:
- Ability to handle technical resources at a variety of levels
- Ability to manage multiple projects across a variety of external clients
- Managing, training and mentoring regulatory associates and/or quality specialists
- Managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies.
- Ensuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
- Developing strategic regulatory approaches for projects, as appropriate with some oversight.
- Planning and conducting formal meetings and teleconferences with regulatory authorities.
- Bachelor’s degree in a related discipline with a minimum of 5 years regulatory affairs experience is preferred; medical device industry experience is needed.
- Master's degree in a related discipline with 2 years regulatory affairs experience is also acceptable.
- Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously while providing options to DLSS clients that work to keep the client in compliance with all appropriate regulations.
- Experience managing and/or mentoring technical resources is highly desired.