Overview
Regulatory Affairs Specialist Jobs in Philadelphia, PA at EPM Scientific
Title: Regulatory Affairs Specialist
Company: EPM Scientific
Location: Philadelphia, PA
Title: Regulatory Affairs Specialist
Summary:
A global leader in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. This position is perfect for a candidate with strong communication and problem-solving skills who is passionate about advancing medical technology. This is a great opportunity to join a cutting-edge organization and play a key role in shaping regulatory strategy and supporting innovative product development.
The Regulatory Affairs Specialist should have the following qualifications:
Bachelor’s or master’s degree in engineering or a technical field
3+ years of regulatory affairs experience in the medical device industry
Proven track record with successful 510(k) submissions
Willingness to work on-site at our Pennsylvania location
Ability to work effectively with cross-functional and risk management teams
Responsibilities of the Regulatory Affairs Specialist include:
Provide regulatory support for medical device projects from development through post-market stages
Coordinate and prepare global regulatory submission documents with cross-functional input
Develop and maintain procedures and work instructions to ensure ongoing regulatory compliance
Collaborate closely with product development teams to implement global regulatory strategies
Monitor changes in regulatory requirements and communicate potential impacts to internal stakeholders
