Description
This position is for a Regulatory Affairs Senior Specialist. If you are interested in preparing submissions for innovative, life-saving devices, then this opportunity is for you. I am looking for candidates who have played major roles in preparing 510(K) clearances. If you have experience working on submissions for software-driven and electronic devices, you are also highly valued. Preferrably, you will have at least three years of experience in regulatory affairs in the medical device industry. A good candidate will have a bachelorsor even bettera masters degree. The team's culture is one of high ambition, energy, and dedication.As senior specialist, you will prepare and write 510(K) clearances to the FDA and other global agencies. You will work to represent the regulatory affairs team in inter-departmental matters. You will mentor less-experienced regulatory affairs specialists and report to the manager and director, providing leadership and advice to all. You will help grow the team and establish its practices for successful device clearances and communication with the FDA.
Position Responsibilities
* Ability to communicate effectively with senior management and regulatory agencies in a manner that supports approval and other key company goals/objectives.
* Strong working relationship with regulatory agencies, geography RA specialist and other functions.
* Strong regulatory knowledge in pre- and post-market submissions, products, and geography regulations.
* Plays a leadership role in effectively planning and driving successful completion of complex projects.
* Participates in development of strategies that leverage opportunities and experiences across functions. Influence and inspire alignment with business goals, internally and externally.
* Review and approve Document Change Orders (COs) for regulatory department.
* Maintain technical knowledge of devices in area of responsibility.
* Solid understanding of product lines/disease states and customers.
* Solid understanding of product distribution release processes and geography launch/maintenance requirements.
* Participate in department systems development initiatives.
* Work with Regulatory Affairs staff, engineers, and technical experts to resolve questions and issues of moderate and high scope and complexity.
* Solid understanding of RA's role and responsibilities within the full quality system and cross-functional roles in the PDP.
* Effectively communicate project plans, status and resource requirements to both core teams and senior management.
* Mentor and teach less experienced Regulatory Affairs Specialists.
If this sounds like a good fit, then I look forward to hearing from you!
To find out more about Real please visit www.realstaffing.com