Description
Position Description:The Sr. Regulatory Affairs Specialist provides and often leads regulatory support for new and existing products within the medical device sector. The Sr. Regulatory Affairs Specialist will implement worldwide regulatory plans and the position typically reports to the Regulatory Affair Manager of Regulatory and Director of Regulatory.
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 and products.
* Plays a leadership role in effectively planning and driving successful completion of 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.
* Solid understanding of product lines/disease states and customers.
* 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 team.
* Mentor and teach less experienced Regulatory Affairs Specialists.
Basic Qualifications:
Education Required:
* Bachelor's degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field. Scientific and Engineering background preferred.
Years of Experience:
* 4+ years w/ Bachelor's degree or 2+ years w/Master's degree experience in Regulatory Affairs, Engineering, Quality or related field.
Specialized Knowledge Required:
* Working knowledge of global medical device regulations, including submissions. Demonstration of technical writing skills.
* Demonstrated Microsoft Word, Excel and Adobe software skills.
* Ability to audit own work to ensure compliance.
* Demonstrated influence skills.
To find out more about Real please visit www.realstaffing.com