Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

Y1ZlUHVvbnE1cnBrNjhQRW96V0IxMlpoc3c9PQ==
  • 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

Buckets cleaning service llc

Housekeeper Job at Buckets cleaning service llc

Hello,Thankyouforyourinterestinworkingwithus! Wearelookingforenergetic, hardworking,reliable,detail-orientedhousecleaners. Noexperiencerequired. We'llteachyoueverythingyouneedtoknowaboutcleaninghouses. Wehelpfamilieswhodon'thave...

Unitas Funding LLC

Business Analyst Job at Unitas Funding LLC

 ...Analyst, Technical Business/Project Manager Job Posting This position is a remote hybrid position requiring being onsite at our corporate office in Cranford, New Jersey, Monday Friday, typically 9am to 5pm as needed. We are seeking a highly motivated individual... 

BRIA

LVN Healthcare Job at BRIA

 ...Growth from within ~ Next day pay available ~ Sign-on bonus*~ Employee rewards program ~ Tuition reimbursement ~ BCBS healthcare coverage ~401k Licensed Practical Nurse (LPN) Responsibilities: As a licensed practical nurse (LPN), you will provide direct... 

Affinity Management Group

Electrician (Journeyman, LME or LMPJ) Job at Affinity Management Group

Exciting Direct Hire Opportunity! Our Client, a diversified global manufacturing company, has an immediate need for an Electrician (Journeyman, LME or LMPJ). In this role you will provide support at a manufacturing plant. This role offers a competitive salary, a comprehensive...

Tata Consultancy Services

UI Developer Job at Tata Consultancy Services

 ...Role: UI Developer Location: Milford, OH (Onsite) Job Type: Full Time Job Description: Respond to user inquiries and issues related to UI and UX. Collaborate with design and development teams to resolve issues. Document and escalate technical problems...