Associate Director of Regulatory Affairs Job at EPM Scientific, San Diego, CA

THBqRnh4OE9BSTU2aUN0bis0alBpd0VwUFE9PQ==
  • EPM Scientific
  • San Diego, CA

Job Description

A globally recognized medical technology innovator is seeking a strategic and experienced Associate Director of Regulatory Affairs to join their team in Southern California. This leadership role is essential in shaping regulatory strategies and ensuring compliance for cutting-edge medical devices across U.S. and international markets. The ideal candidate will bring deep regulatory expertise, a strong background in software-based medical technologies, and a passion for advancing health-care solutions.

The Associate Director should have the following qualifications:

  • Bachelor's degree in engineering, life sciences, or a related field (Master's preferred)
  • Regulatory Affairs Certification (RAC) strongly preferred
  • Minimum of 10 years of regulatory affairs experience in the medical device industry, including 5+ years focused on Software as a Medical Device (SaMD)
  • Demonstrated success in preparing and submitting regulatory applications (e.g., FDA, Health Canada)
  • In-depth knowledge of U.S., Canadian, and international medical device regulations
  • Proven ability to collaborate across functions including R&D, Quality, and Marketing
  • Strong communication, project management, and analytical skills
  • Willingness to work on site 4 days per week

Responsibilities of the Associate Director include:

  • Lead regulatory activities for new product development, labeling updates, and promotional submissions
  • Develop and execute regulatory strategies to support product approvals and global market access
  • Prepare and manage submissions including 510(k), EU MDR, and CE Mark documentation
  • Review and approve product labeling, advertising, and promotional content for regulatory compliance
  • Collaborate with internal teams and external consultants to ensure timely and successful project execution

Job Tags

Similar Jobs

Cornerstone General Contractors

Accounts Payable and Administration Specialist Job at Cornerstone General Contractors

 ...Title: Accounts Payable and Administration Specialist Reports to: Accounting Manager Annual Salary: $40K to $60K - DOE Since 1993, Cornerstone General Contractors, Inc., has fostered a flexible approach to commercial construction based on cooperation, innovation... 

EPITEC

Risk Manager Job at EPITEC

 ...Job Title: Commercial Insurance Program - Risk Manager Contract Duration: 7 months; possible extension Location: Norfolk, VA...  ...involved in the project. Prepare presentations and reports using MS Office Suite (Word, Excel, PowerPoint). Monitor risk management,... 

Raymond James Financial, Inc.

Practice Management Consultant Job at Raymond James Financial, Inc.

 ...advisory teams with guidance provided by senior coaches and management. May lead defined work or projects of fundamental...  ...one on one and team coaching, group coaching, and consultations to advisory teams on practice and business management issues. Evaluates end results... 

Infosys

Elastic Search, Kafka Developer Job at Infosys

Infosys is seeking an Elastic Search, Kafka Developer - In the role, you will interface with key stakeholders and apply your technical proficiency across different stages of the Software Development Life Cycle including Requirements Elicitation, Application Architecture...

Career Group

Personal Assistant Job at Career Group

 ...Personal Assistant to UHNW Individual Beverly Hills Location: Beverly Hills, CA Compensation: $140,000/year A prominent ultra-high-net-worth individual based in Beverly Hills is seeking a top-tier Personal Assistant to provide seamless support across both...