Regulatory Affairs Manager Job at BioPhase, San Diego, CA

eUtCaTJMQXFFaVphMkVRVWsrdHQvNk1oM1E9PQ==
  • BioPhase
  • San Diego, CA

Job Description

Regulatory Affairs Manager

Location: San Diego, CA (Onsite)

Salary Range: $145,000 - $165,000

Job Summary

BioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency communications, ensuring compliance with FDA, EU IVDR, and global regulations. The ideal candidate will collaborate cross-functionally and drive regulatory excellence.

Responsibilities

  • Develop and execute global regulatory strategies for IVD products.
  • Lead preparation of 510(k), IVDR Technical Documentation, and other regulatory submissions.
  • Manage regulatory assessments for product changes and compliance.
  • Collaborate with R&D, Quality, Manufacturing, and Marketing teams.
  • Mentor and lead a team of regulatory professionals.
  • Monitor global regulatory trends and implement best practices.
  • Support regulatory inspections and audits.

Qualifications

  • Bachelor’s degree in Bioengineering, Biochemistry, Molecular Biology, or related field (Advanced degree preferred).
  • 8+ years in Regulatory Affairs, with 5+ years in IVD regulatory roles.
  • Experience securing approvals in US, EU IVDR, Canada, Australia, etc.
  • Strong leadership and cross-functional collaboration skills.
  • Proficiency in regulatory submission tools and Microsoft Office Suite.

Work Environment & Travel

  • Onsite in San Diego, CA.
  • Limited travel (<10%).

Job Tags

Similar Jobs

MTSS

Phlebotomy - Phlebotomist I Job at MTSS

 ...Requirements: Ability to provide quality, error free work in a fast-paced environment....  ...on-site supervision. Excellent phlebotomy skills to include pediatric and geriatric...  ...school diploma or equivalent. Medical training: medical assistant or paramedic training... 

Gulfstream Strategic Placements, LLC

HVAC Service Technician Job at Gulfstream Strategic Placements, LLC

 ...HVAC Service Technician job in Fort Meyers, FL This is a permanent, full time position offering a competitive salary and benefits package...  ...Responsibilities: Install, repair, and replace HVAC equipment for commercial TI and Service projects Communicate with vendors and... 

International Staffing Consultants, Inc.

Senior Litigation Associate, Attorney Job at International Staffing Consultants, Inc.

 ...an exciting opportunity for a seasoned attorney to engage in complex and high-profile cases...  ...base. The role is based in Irvine with remote work options available. Key...  ...Drafting Mastery: Craft sophisticated legal documents, including class/collective certification... 

Milton Hershey School

Houseparents, Full-Time - Relocation to Hershey, PA Required Job at Milton Hershey School

 ...nurturing family-like environment for students in grades pre-K to 12 from disadvantaged backgrounds. Married couples live on campus, teaching life skills while handling daily responsibilities and promoting a supportive atmosphere. This unique full-time position offers... 

All Star Healthcare Solutions All Star Healthcare Solutions

Full Time Geriatrics Job FL Job at All Star Healthcare Solutions All Star Healthcare Solutions

 ...Approx 18-25 patients per day Shared call Must have strong experience with Medicare Advantage patients and coding for STARS & HEDIS measures. Fast track to Senior compensation, which includes profit sharing in ACO, Ancillary Services, and Real Estate opportunities...