Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

eFRCTXY0ZldvZ1VrckdnVjNhZ1Q3OEdzY1E9PQ==
  • 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

TBG | The Bachrach Group

Residential Real Estate Closing Attorney Job at TBG | The Bachrach Group

 ...TBG I The Bachrach Group is engaged in a search with a prominent Real Estate Law Firm with multiple locations searching for a new member for their Real Estate Team in their Blue Ridge office. 0-2 years experience doing real estate closings and clearing title. Will look... 

El Encanto, A Belmond Hotel

Server PM Job at El Encanto, A Belmond Hotel

 ...Pond, have been lovingly restored. Modern additions to the expansive outdoor zero-edge pool and a new, beautifully appointed boutique spa enhance the journey for todays luxury-seeking guest. With our vast offerings, the opportunities to craft a unique career here are... 

Yoh, A Day & Zimmermann Company

Materials Coordinator - LA (Santa Monica) /Part Time Morning Shift/Weekend Job at Yoh, A Day & Zimmermann Company

 ...Materials Coordinator - Los Angeles (Santa Monica)/Part Time, Weekend Morning Shift Shift Days/Hours: Saturday and Sunday, 12-hour shifts. 6am-6pm. Scope: Handle the following Receive, unpack, check & verify merchandise/product ensuring accuracy... 

VST Engineering Inc.

Design Engineer Job at VST Engineering Inc.

 ...VST is seeking a Design Engineer for a remote position in the Bay Area. The ideal candidate should possess robust design capabilities in Civil 3D and production planning. Draw, update, and maintain designs Manage multiple complex projects at the same time Ensure... 

LHH

Purchasing Assistant Job at LHH

We're Hiring: Purchasing Clerk On-site: Temecula Are you a detail-oriented professional with a knack for organization and vendor coordination? Join our team as a Purchasing Clerk and play a key role in supporting operations across our U.S. facilities. What...