MIP Job Announcement | Regulatory Associate

We are looking for an experienced Regulatory Associate to work as a remote consultant with MedTech Impact Partners.

Responsibilities

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process

• Provide varying levels of support to the regulatory team

• FDA meeting preparation as needed

• Proposal writing

Qualifications

• Minimum of 2 to 5 years of Regulatory experience

• Relevant experience in proposal writing

• Proven successful track record of authoring/submitting FDA submissions (Pre-Submissions, 510(k), De Novo) and Draft Regulatory Strategies, CE experience a plus

• Previous experience working directly with the FDA

• Regulatory Affairs Credentials (RAC) a plus

• Strong organizational skills with attention to detail

MedTech Impact Partners is a medical device regulatory strategy consulting firm, leveraging deep executive-level experience from the USFDA, private sector and world-class research to deliver expert insights for companies, law firms and investors. MedTech Impact’s work results in improved compliance for medtech companies, expert interpretation of FDA laws, regulations and policies for law firms, and enhanced diligence for venture capital firms.