Government Affairs Representative supports the implementation of strategic plans and engagement objectives to develop and maintain productive relations with all levels of government authorities to achieve business goals. Liaises with government entities (federal, state, provincial, or local) that regulate or influence business activities. Being a Government Affairs Representative collaborates with industry groups and organizations with complementary objectives to achieve objectives. Monitors and analyses proposed legislation, emerging issues, and trends and prepare reports and informational documents to inform and support business leaders. Additionally, Government Affairs Representative requires a bachelor's degree in public policy, public administration, business or equivalent. Typically reports to a manager. The Government Affairs Representative work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. To be a Government Affairs Representative typically requires 4 -7 years of related experience. (Copyright 2024 Salary.com)
About Us:
Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. We self-fund our projects through preclinical development and work with financial partners for clinical development and commercialization. Our portfolio of hydrogel technology positions us to be the leader in creating new hydrogel based medical devices to address unmet medical needs in a range of surgical interventions. We have launched over ten medical device companies based on this unique technology. These companies have generated over $4B in value, and have helped over 5 million patients worldwide achieve better outcomes.
Position Summary:
The Regulatory Affairs Manager is responsible for developing and implementing strategies to ensure compliance with regulatory standards and requirements for Pramand’s medical device products. This role advises development teams, prepares regulatory documentation, and interacts with regulatory agencies to gain marketing approval for Pramand’s products in various territories.
Principal Duties and Responsibilities:
Supervisory Responsibilities:
This role will be involved in identifying resource needs, recruiting candidates, and onboarding new hires as the organization evolves.
Qualification Requirements:
Education:
Bachelor’s degree in a scientific discipline or with relevant experience
Experience:
5 years experience in medical device regulatory affairs.
Knowledge/Skill:
Working Conditions:
Duties of this position are performed in good working conditions. Occasional exposure to elements such as noise, dust, chemicals, operating machinery, temperature extremes, etc.
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