Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

T1hvWDJxQk55ckV4ZE5wNUREbVovVHcwaVE9PQ==
  • 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

Lands' End

Assistant Designer - Lands' End Outfitters (Hybrid) Job at Lands' End

 ...with onsite presence required 10 days per month. As an Assistant Designer you are responsible for assisting in the design and development...  ...original designs. A keen eye for detail and a passion for fashion and home decor. Physical Requirements Ability to sit for... 

Northwestern Medicine

Housekeeping Assistant Specialist II Job at Northwestern Medicine

 ...Center team. ~ All assigned Conference Rooms must be monitored and cleaned on all hospital floors, including but not limited to 10-560, 7-3...  ...with appropriate cleaner/polish; ~ Trash Cans: Empty each night and thoroughly wash and disinfect trash cans at least once... 

New Generation Academy

Elementary Math and English Language Arts Tutor Job at New Generation Academy

 ...New Generation Academy, a fully accredited school, is seeking to hire Math and ELA tutors for Grades 1 - 5. We prefer individuals who can tutor both Math and ELA content. Job Description (Required): Tutors must be proficient in Math and ELA content in Grades... 

Astrix

Environment, Health and Safety Manager Job at Astrix

 ...Senior Environmental Health and Safety (EHS) Manager Position Summary: The Senior EHS Manager is responsible for leading, developing...  ..., and federal regulations, as well as corporate standards and industry best practices. This role is integral to fostering a culture of... 

Core Medical-Perm

Staff - Registered Nurse (RN) - PACU - Post Anesthesia Care - $32-52 per hour Job at Core Medical-Perm

 ...Core Medical-Perm is seeking a Registered Nurse (RN) PACU - Post Anesthesia Care for a nursing job in Concord, New Hampshire. Job Description & Requirements ~ Specialty: PACU - Post Anesthesia Care ~ Discipline: RN ~ Start Date: ASAP ~ Duration: Ongoing...