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Job #03584

About our client Our client is a medical device company based in Southborough, MA. They were recently purchased by an international opto-digital technology company. Together, they focus on the design, development and manufacturing of devices that allow medical professionals to perform safe and invasive-free surgery. Their products feature a comprehensive portfolio of instruments designed to improve visualization and provide fast, accurate tissue management that is less traumatic to the patient. With over 100 employees based in Southborough and many locations overseas, this is an excellent opportunity for the right person to join a fast-paced environment! Position Location International Regulatory Affairs Specialist Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist the Vice President of Regulatory Affairs in obtaining approval to market the company in the worldwide markets 2) Participate in product teams developing new products to define global regulatory requirements 3) Assist the International Regulatory Affairs Team with product registrations in markets such as Japan, Asian New Frontier Markets, Australia and Latin America 4) Work with Regulatory Affairs Associates to obtain certificates of product for export or other applicable export notifications from FDA as needed 5) Assist with maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information 6) Provide reports to management concerning current, pending and future approvals to management. 7) Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to the company’s products and processes 8) Advise regulatory management of changes and communicate regulatory initiatives or changes to staff 9) Assist with tracking external standards applicable to company products and processes and maintain a corporate standards library/index 10) Communicate proposed/implemented changes to company staff. 11) Develop and maintain regulatory procedures to ensure consistent, efficient and compliant regulatory processes 12) Assist with development, coordination, preparation and maintenance of “Core International” medical device submissions such as EU design dossiers & technical files and Canadian Class 2, 3 or 4 submissions Requirements 1) BS/BA in Engineering or Life Sciences 2) Minimum 3 – 5 years of regulatory affairs experience in the Medical Device industry 3) International experience (preferably Asian) 4) Experience in preparing and submitting regulatory documentation and 510k submissions 5) RAC accreditation (through RAPS) a plus 6) Excellent communication (oral and written) and computer skills (MS Office suite) 7) Strong critical-thinking, problem-solving, planning and organization 8) Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors 9) Ability to meet deadlines and be detailed-orientated 10) Good planning and organization skills 11) Ability to work in small team environment 12) Self-starter with ability to work independently