IQVIA
Director, Regulatory Affairs, EMC/Robotics
IQVIA, Washington, District of Columbia, us, 20022
Director, Regulatory Affairs, EMC/Robotics
Join to apply for the
Director, Regulatory Affairs, EMC/Robotics
role at
IQVIA .
Overview The Director, Regulatory Affairs, EMC/Robotics will be a critical team member supporting regulatory strategy and submissions for
Robotics
and
Electromagnetic Compatibility (EMC)
clientele. The primary roles and responsibilities include managing the development of regulatory submissions, developing overall regulatory strategy, communicating with regulatory bodies and clients, managing project personnel, and acting as a mentor and trainer for junior employees.
Responsibilities and Duties
Develop and execute regulatory services for client companies, including but not limited to:
Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)
Regulatory Strategy, Analysis & Development
Design, Review & Implement Pre-Clinical Testing
Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed accurately and timely.
Lead/manage business development functions to secure new clients and projects.
Develop project and departmental budgets and timelines, as required.
Work directly with client companies and/or regulatory bodies without oversight.
Provide project leadership while maintaining sole relationship with client companies.
Lead people development projects, working alongside team managers, as required.
Work collaboratively with seminar MCRA departments, including clinical, RHEMA, and quality assurance.
Work with other department heads and executive management to guide progress and development of the regulatory department and company, as required.
Required Knowledge, Skills, and Experience
Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
Experience: Minimum ten years of experience in Regulatory Affairs related to development of medical devices, drugs, and/or biologics, developing regulatory deliverables and submissions. Experience must include project management and/or managerial experience.
Required: Experience in Robotics and Electromagnetic Compatibility (EMC).
Exposure to navigation systems or navigation instruments within robotics.
Experience with a robotics start‑up is a plus.
Other
An understanding of clinical research and data analysis is required.
Possesses US and/or International regulatory experience/flu Hitch regulatory experience including FDA, Notified Body, ISO 13485.
Domain‑specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.
Understanding of the team’s regulatory landscape, including breadth of services, interactions, and data flow between deliverables.
Strong attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and vendors.
Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.
Possesses an understanding of engineering and biological background to assist with pre‑clinical and clinical strategies and effectively communicate these to internal team members and clients.
Able to creatively think through potential solutions and present them skillfully on paper.
Strong research, analytical, critical‑thinking, and problem‑solving skills.
Strong professionalism with customer relations and managing client relationships.
Ability to lead a team effectively, mentor junior members, and be accountable for team utilization, as required.
Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates high‑level self‑accountability.
Excellent organizational and prioritization skills to handle multiple tasks and meet deadlines independently.
PC/Technical skills – MS Office, Excel, Word, PowerPoint.
Must be punct, polished, and professional.
Effective interpersonal skills: confident subject matter expertise and calm‑under‑pressure approach and style.
Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $107,800.00 - $300,400.00. The actual base pay offered may vary based on a number of factors including job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and naalakkersuis and other benefits.
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Director, Regulatory Affairs, EMC/Robotics
role at
IQVIA .
Overview The Director, Regulatory Affairs, EMC/Robotics will be a critical team member supporting regulatory strategy and submissions for
Robotics
and
Electromagnetic Compatibility (EMC)
clientele. The primary roles and responsibilities include managing the development of regulatory submissions, developing overall regulatory strategy, communicating with regulatory bodies and clients, managing project personnel, and acting as a mentor and trainer for junior employees.
Responsibilities and Duties
Develop and execute regulatory services for client companies, including but not limited to:
Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)
Regulatory Strategy, Analysis & Development
Design, Review & Implement Pre-Clinical Testing
Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed accurately and timely.
Lead/manage business development functions to secure new clients and projects.
Develop project and departmental budgets and timelines, as required.
Work directly with client companies and/or regulatory bodies without oversight.
Provide project leadership while maintaining sole relationship with client companies.
Lead people development projects, working alongside team managers, as required.
Work collaboratively with seminar MCRA departments, including clinical, RHEMA, and quality assurance.
Work with other department heads and executive management to guide progress and development of the regulatory department and company, as required.
Required Knowledge, Skills, and Experience
Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
Experience: Minimum ten years of experience in Regulatory Affairs related to development of medical devices, drugs, and/or biologics, developing regulatory deliverables and submissions. Experience must include project management and/or managerial experience.
Required: Experience in Robotics and Electromagnetic Compatibility (EMC).
Exposure to navigation systems or navigation instruments within robotics.
Experience with a robotics start‑up is a plus.
Other
An understanding of clinical research and data analysis is required.
Possesses US and/or International regulatory experience/flu Hitch regulatory experience including FDA, Notified Body, ISO 13485.
Domain‑specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.
Understanding of the team’s regulatory landscape, including breadth of services, interactions, and data flow between deliverables.
Strong attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and vendors.
Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.
Possesses an understanding of engineering and biological background to assist with pre‑clinical and clinical strategies and effectively communicate these to internal team members and clients.
Able to creatively think through potential solutions and present them skillfully on paper.
Strong research, analytical, critical‑thinking, and problem‑solving skills.
Strong professionalism with customer relations and managing client relationships.
Ability to lead a team effectively, mentor junior members, and be accountable for team utilization, as required.
Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates high‑level self‑accountability.
Excellent organizational and prioritization skills to handle multiple tasks and meet deadlines independently.
PC/Technical skills – MS Office, Excel, Word, PowerPoint.
Must be punct, polished, and professional.
Effective interpersonal skills: confident subject matter expertise and calm‑under‑pressure approach and style.
Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $107,800.00 - $300,400.00. The actual base pay offered may vary based on a number of factors including job‑related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part‑time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and naalakkersuis and other benefits.
#J-18808-Ljbffr