Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

QjR1UW9tWk9CVCtOUVBJZ0RCM2J5azc3OXc9PQ==
  • EPM Scientific
  • Philadelphia, PA

Job Description

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

B&W Quality Growers, LLC

Assistant Grower Job at B&W Quality Growers, LLC

 ...re looking for a hands-on Field Supervisor to oversee daily farm operations, lead field crews, and ensure top-quality harvests....  ...QUALIFICATIONS EDUCATION and/or EXPERIENCE Associated degree in agriculture or related area or 5+ years of experience in agriculture.... 

Zoom Casa

Sales Manager Job at Zoom Casa

Pay: From $120,000.00 per year + incentive compensation Job description: About Zoom Casa Zoom Casa is revolutionizing residential real estate with a direct sales model that puts homeowners in control of the sale of their home. Our flagship product, Cash +, ...

MillerBlowers, Inc.

Trusts & Estates Attorney Job at MillerBlowers, Inc.

 ...An attorney with at least three year's experience in estate planning and probate wanted for high end Sarasota law firm. Duties include drafting sophisticated estate planning documents, preparing probate documents and working with wealthy clients. This firm has an outstanding... 

Blinds To Go

Director of Sales-Shop At Home (Paramus) Job at Blinds To Go

 ...support to BTG partners Work with installation managers to build installation network and maintain excellent service levels in remote markets Help identify and qualify installers as needed Measure installation service levels Work with stores leadership to... 

Bystronic Inc.

Technical Trainer Job at Bystronic Inc.

Who we are. What we do. We are Bystronic a global technology company passionate about creating an impact for a sustainable future with sheet metal and beyond. We want to work with people who support us in creating innovative solutions to move our industry forward...