Job Description

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

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