BioSpace
Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid
BioSpace, Irvine, California, United States, 92620
Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote) Join to apply for the
Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)
role at
BioSpace . Company Description
Do you have the right skills and experience for this role Read on to find out, and make your application. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok. Job Description The Associate Director, Regulatory Affairs Devices and Combination Products collaborates with internal and external partners to deliver products to patients. Responsibilities include supporting regulatory objectives for development and marketed device/combination products, managing global submissions, and CE technical files/design dossiers. The role involves supporting regulatory submissions such as CE mark, US PMAs, IDEs, 510(k), DE NOVO, post-approval reports, and more. The employee will develop regulatory strategies, contribute to the preparation of regulatory submissions, monitor regulatory legislation, and support agency and industry meetings. Additionally, the role involves supporting MDR implementation, due diligence, and regulatory audits, ensuring compliance with all relevant laws and policies. This position focuses on eye care devices and next-generation eye care medicinal delivery products. Responsibilities Develop and prepare pre-market regulatory submissions, securing regulatory clearance/approvals for in vitro diagnostic products and device strategies. Manage regulatory applications, including investigational applications, technical files, and post-approval changes. Oversee change control processes and ensure regulatory compliance. Prepare for and manage regulatory agency meetings, serving as the primary contact. Inform regulatory management of key issues and trends. Train and mentor team members, possibly including supervisory duties. Develop policies within the regulatory affairs department. Analyze legislation and provide regulatory guidance. Represent RA Device in product development and regulatory teams. This position can be based in AbbVie's Irvine, CA office or remotely within the US. Qualifications Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field. Relevant advanced degree and certification are a plus. Minimum 12+ years of pharmaceutical or industry experience, with 5+ years in quality systems or regulatory affairs, and 7+ years in leadership roles. Experience in complex matrix environments, with strong communication skills. Preferred experience includes 5+ years in regulatory affairs, 10+ years in pharmaceutical industry, and 5+ years in discovery, R&D, or manufacturing. Additional Information The compensation range is $83,898.06 to $261,000 annually, depending on location and experience. Benefits include paid time off, medical/dental/vision insurance, 401(k), and participation in incentive programs. AbbVie is an equal opportunity employer committed to diversity and inclusion. Job Details Seniority level: Director Employment type: Full-time Job function: Legal
#J-18808-Ljbffr Remote working/work at home options are available for this role.
Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)
role at
BioSpace . Company Description
Do you have the right skills and experience for this role Read on to find out, and make your application. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok. Job Description The Associate Director, Regulatory Affairs Devices and Combination Products collaborates with internal and external partners to deliver products to patients. Responsibilities include supporting regulatory objectives for development and marketed device/combination products, managing global submissions, and CE technical files/design dossiers. The role involves supporting regulatory submissions such as CE mark, US PMAs, IDEs, 510(k), DE NOVO, post-approval reports, and more. The employee will develop regulatory strategies, contribute to the preparation of regulatory submissions, monitor regulatory legislation, and support agency and industry meetings. Additionally, the role involves supporting MDR implementation, due diligence, and regulatory audits, ensuring compliance with all relevant laws and policies. This position focuses on eye care devices and next-generation eye care medicinal delivery products. Responsibilities Develop and prepare pre-market regulatory submissions, securing regulatory clearance/approvals for in vitro diagnostic products and device strategies. Manage regulatory applications, including investigational applications, technical files, and post-approval changes. Oversee change control processes and ensure regulatory compliance. Prepare for and manage regulatory agency meetings, serving as the primary contact. Inform regulatory management of key issues and trends. Train and mentor team members, possibly including supervisory duties. Develop policies within the regulatory affairs department. Analyze legislation and provide regulatory guidance. Represent RA Device in product development and regulatory teams. This position can be based in AbbVie's Irvine, CA office or remotely within the US. Qualifications Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field. Relevant advanced degree and certification are a plus. Minimum 12+ years of pharmaceutical or industry experience, with 5+ years in quality systems or regulatory affairs, and 7+ years in leadership roles. Experience in complex matrix environments, with strong communication skills. Preferred experience includes 5+ years in regulatory affairs, 10+ years in pharmaceutical industry, and 5+ years in discovery, R&D, or manufacturing. Additional Information The compensation range is $83,898.06 to $261,000 annually, depending on location and experience. Benefits include paid time off, medical/dental/vision insurance, 401(k), and participation in incentive programs. AbbVie is an equal opportunity employer committed to diversity and inclusion. Job Details Seniority level: Director Employment type: Full-time Job function: Legal
#J-18808-Ljbffr Remote working/work at home options are available for this role.