Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

bUw4VlorcC9Ba0lzTjg4LzJxaFBRM2FqQVE9PQ==
  • EPM Scientific
  • Philadelphia, PA

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

Job Tags

Similar Jobs

Motion Recruitment

Data Governance Manager Job at Motion Recruitment

 ...DETAILS: Domain: Banking Position: Data Project Manager Duration: 12 Months (Possibility of extension or conversion) Location: Irving, TX (Hybrid 2 Days/Week Onsite) In this role, you will gain detailed understanding of our execution approach to and deliver... 

Strativ Group

ML Research Scientist Job at Strativ Group

 ...About the Role Were working with a leading AI research team advancing foundational models for drug discovery. They work at the intersection of machine learning, engineering, and computational chemistry to advance the development of novel therapies. This is a rare... 

ThunderSoft

Legal Intern Job at ThunderSoft

 ...technology with one of the worlds leading tech companies. As an IP Intern, you will: Work on real-world IP projects alongside Qualcomm...  ...mentor and supported by a collaborative team environment Develop skills and knowledge critical for a successful career in patent... 

New York Technology Partners

Actimize Developer Job at New York Technology Partners

Actimize Developer Location Charlotte, North Carolina - onsite daily Note from HM: candidates who have also worked at TCS, Infosys or Wipro would be ideal Must Haves: Extensive experience in NICE Actimize IFM-X Design and implement custom models within ...

The Agency

Landscape Designer Job at The Agency

 ...is representing a client in need of a creative and meticulous Landscape Designer. The successful candidate will blend artistic...  ...Education : A Bachelors or Masters degree in Landscape Architecture, Landscape Design, or a related field is required. Experience...