Senior Regulatory Affairs Director

2 months ago


California, United States The Mullings Group Full time

Job Title: Senior Regulatory Affairs Leader

About The Mullings Group: A leading consulting firm specializing in medical device regulatory affairs and strategic business development.

Job Summary: We are seeking a highly experienced Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations for our medical device clients.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with FDA regulations and guidelines.
  • Lead cross-functional teams to prepare and submit PMA applications, 510(k) submissions, and other regulatory documents.
  • Collaborate with clients to understand their business needs and develop tailored regulatory solutions.
  • Stay up-to-date with changing regulatory requirements and industry trends.
  • Provide regulatory guidance and support to clients throughout the product lifecycle.

Requirements:

  • Proven experience in regulatory affairs, preferably in the medical device industry.
  • Strong knowledge of FDA regulations and guidelines, including PMA and 510(k) submissions.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.

Preferred Qualifications:

  • Background in cardiovascular solutions or alternative medical implantables, robotics, and/or class III medical electronics.
  • Experience with PMA approval and post-market supplements.
  • Knowledge of international regulatory requirements.


  • California, United States Trebla Talent Full time

    Regulatory Affairs DirectorJoin Trebla Talent in our mission to find the best talent for our clients.Company Overview:Trebla Talent is a leading recruitment agency specializing in the life sciences industry. We are committed to providing exceptional service and expertise to our clients and candidates.Job Summary:We are seeking an experienced Regulatory...


  • California, USA, United States Bow and Arrow Holdings, LLC Full time

    Job Title: Director of Regulatory AffairsWe are seeking an experienced Director of Regulatory Affairs to join our team at Bow and Arrow Holdings, LLC. As a key member of our organization, you will be responsible for developing and executing advocacy strategies that support distributed generation development on residential real estate in our target...


  • California, United States Meet Full time

    Regulatory Affairs and Quality Assurance LeaderWe are seeking a seasoned Regulatory Affairs and Quality Assurance professional to join our client's team as a Vice President/Senior Vice President. This hybrid role will be based in the San Francisco Bay Area and will report directly to the C-Suite.Key Responsibilities:Lead the Regulatory Affairs and Quality...


  • California, USA, United States Planet Pharma Full time

    Job Title: Regulatory Affairs Associate Director/DirectorPlanet Pharma is seeking a highly skilled Regulatory Affairs Associate Director/Director to join our team in South San Francisco, CA. This is a 6-month contract opportunity.Key Responsibilities:Develop and implement competitive and effective global regulatory strategies for oncology products, including...


  • California, United States The Mullings Group Full time

    Job SummaryThe Mullings Group is seeking a highly skilled Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations for our client, a transformational new medtech start-up utilizing advanced robotics to combat structural heart disease.About the...


  • California, United States Bow and Arrow Holdings, LLC Full time

    Job Title: Director of RegulatoryCompany OverviewBow and Arrow Holdings, LLC is a leading provider of flexible infrastructure solutions. Our mission is to generate life-long current yield for our partners and shareholders by delivering resilience and independence to our customers.Job SummaryWe are seeking an experienced Director of Regulatory to join our...


  • California, United States Edwards Lifesciences Full time

    Make a Meaningful Difference in Regulatory AffairsAt Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Senior Specialist, Regulatory Affairs, Critical Care, you'll play a critical role in helping us achieve this vision.Key Responsibilities:Represent the...


  • California, United States Edwards Lifesciences Full time

    Make a Meaningful Difference in Regulatory AffairsAt Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Regulatory Affairs Specialist, you'll play a critical role in helping us achieve this vision by ensuring our innovative technologies meet complex domestic and...


  • California, United States BioTalent Full time

    BioTalent is seeking a seasoned Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. As a key member of our team, you will develop and implement global regulatory strategies for clinical applications in various markets. Your expertise will be crucial in managing regulatory submissions, collaborating with clinical...


  • California, United States Edwards Lifesciences Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Edwards Lifesciences. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesRepresent the regulatory function on manufacturing and...


  • California City, California, United States Shell Full time

    Key ResponsibilitiesThe Regulatory Affairs Director will play a critical role in supporting Shell Energy's wholesale/retail trading/origination businesses and Shell Renewable and Energy Solutions related businesses through external advocacy for competitive markets, communicating regulatory changes and impacts of regulatory changes to commercial teams,...


  • California, United States Edwards Lifesciences Full time

    Make a Meaningful Difference in Critical CareAt Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Regulatory Affairs Specialist, you'll play a critical role in helping us achieve this vision.Your ImpactRepresent the regulatory function on manufacturing and...

  • Senior CMC Director

    2 months ago


    California, United States Meet Full time

    Title: Senior Director, CMCOverview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in guiding and managing CMC initiatives pertaining to the development, manufacturing, and supply chain of drug substances and products. This position...


  • California, United States Edwards Lifesciences Full time

    About Edwards LifesciencesEdwards Lifesciences is a leading global medical technology company that specializes in the development, manufacturing, and marketing of innovative medical devices. Our mission is to improve the quality of life for patients around the world by providing cutting-edge medical solutions.Job SummaryWe are seeking a highly skilled...


  • California, USA, United States KayeBassman International Full time

    Medical Affairs Leader OpportunityKaye/Bassman International is proud to present a unique opportunity for a seasoned Medical Affairs professional to join a San Francisco-based biopharma company.The company is a clinical stage organization with a single asset in development targeting three indications focused on liver and metabolic diseases, where there are...


  • California, Missouri, United States Invenergy Full time

    Job Title: Senior Manager, Government AffairsInvenergy is seeking a highly skilled and experienced Senior Manager to join our Government Affairs team in Sacramento, California. As a key member of our team, you will be responsible for developing and implementing strategies to educate and influence government policies in California.Key Responsibilities:Develop...


  • California, United States Vir Biotechnology, Inc. Full time

    THE OPPORTUNITY Vir Biotechnology is seeking an experienced Senior Director to be the Head of our Medical Safety function. Within Vir’s Global Pharmacovigilance & Risk Management (PVRM) department, you will provide medical expertise and strategic direction while overseeing the medical safety team, including responsibility for signal management, risk...


  • California, United States Meet Full time

    Title: Senior Director, CMCOverview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in directing and managing CMC functions associated with the development, manufacturing, and supply chain of drug substances and products. This position...


  • California, USA, United States Sunrise Senior Living Full time

    Job Title: Resident Care Director - LVNAt Sunrise Senior Living, we are committed to providing high-quality care and services to our residents. We are seeking a skilled and compassionate Resident Care Director - LVN to join our team.Job Summary:The Resident Care Director - LVN is responsible for leading and managing the health and wellness of our residents....


  • California, USA, United States Barrington James Full time

    Senior Director, Biostatistics - Biotech (SAN DIEGO) - ON-SITE / HYBRIDWe are collaborating with a leading Biotech company to find a Senior Director, Biostatistics.The company is working on treatments for rare diseases, with a pipeline including 4 Phase II studies and a pivotal Phase III study.The ideal candidate will have:A Master's or Ph.D. in Statistics...