SUMMARY:
The Sr. Regulatory Affairs Specialist manages projects regarding facility regulatory strategies and systems to assure that applicable local, national, and international requirements are met. This position assists in implementing the policy for determining appropriate, comprehensive, and effective quality system and regulatory compliance.
RESPONSIBILITIES:
• Project manages and prepares assigned US and non-US product submissions (technical files, Canadian licenses and international registrations).
• Participate in product development project teams, as well as, review, analyze and comment on technical reports. Develop regulatory project plans and manage regulatory projects in support of Product Development projects.
• Review, approve and provide guidance for labeling and advertising.
• Counsel technical and business groups to establish directions based on available data and regulatory considerations.
• Provide input and comment to regulations and standards which may affect company's device products.
• Provide training on regulatory requirements and issues to company personnel to assure full understanding and consistent compliance
• Provide import/export information and documentation as required to support international sales and shipment of product.
• Maintain knowledge and application skills of regulations and standards with job scope
• Perform other regulatory duties as assigned.
QUALIFICATIONS:
• BA/BS degree in a business, engineering, medical or scientific discipline.
• Minimum of 4-6 years of regulatory experience in medical device regulatory function(s) commensurate with accountabilities describe above.
• Experience in managing, preparing and submitting class II marketing applications to regulatory agencies
• Knowledge and understanding of US, European and International medical device regulations, standards and guidance documents.
• Minimum of 3 year experience with software driven devices
• Minimum of 3 year experience in working with regulatory agencies (i.e. FDA) and competent authorities
• Knowledge and understanding of QSR and ISO quality management systems documentation requirements
• Regulatory Affairs certification (RAC) a plus
• Demonstrable record of managing projects utilizing cross-functional teams while working multiple projects
• Must be able to work with minimal supervision, recognize departmental and organizational needs, and initiate actions/recommendations for resolution.
Location: Andover, MA
Duration: FTE - full time permanent position
Rate Target: DOE.
If you have interest in this position, please contact me immediately.
GTT has over 8 years of experience in IT consulting, including staff augmentation and project engagements. We offer health insurance, 401K, and disability insurance to W2 employees. Also, we will contract on a Corp to Corp basis.
****This is a full time position. Third party resumes will not be accepted!****
Please send Word version of resume to medicaldevicejobs@grouptechinc.com and reference this ad when applying.
Denotes required fields.