Director Cardiovascular Regulatory Affairs Interventional
Director Cardiovascular Regulatory Affairs Interventional
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Job Description
Position Responsibilities:
- Develop and execute regulatory services for client companies including however not limited to:
- Regulatory Submissions 510(k) IDE PMA IND BLA & IND)
- Regulatory Strategy Analysis & Development
- Design Review & Implement Analytical and Clinical Testing
- Manage junior members of MCRAs regulatory department.
- Assist in business development functions (i.e. provide insight on BD calls bid defenses etc. to secure new clients and projects.
- Work directly with client companies and/or FDA without Director or other leadership oversight.
- Provide project leadership while maintaining sole relationship with client companies.
- Work collaboratively with other MCRA departments including clinical reimbursement and quality assurance.
- Work with other regulatory leadership to help guide the progress and development of the spine team and the regulatory department.
- Technical writing and review of documents and deliverables.
- Represent MCRA at conferences and meetings as needed.
- Complete other duties and projects as assigned.
- Ensure all work products comply fully with standards policies and mission of MCRA.
Required Qualifications:
- Bachelors degree in a scientific discipline (engineering or a heavily technical writingbased curriculum preferred); Master of Science Master of Science in Engineering or PhD preferred.
- Previous or current agency experience is required.
- 7 years of regulatory affairs experience required.
- 4 years of cardiovascular medical device experience required. The ideal candidate will have direct experience in one or more of the following device areas:Cardiac Interventional Devices
- Strong attention to detail and the ability to work individually within a multidisciplinary team as well as with external partners and vendors.
- Possesses engineering and/or biological background to assist with preclinical and clinical strategies and can effectively communicate these strategies to internal team members and clients.
- Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international regulatory affairs and the regulatory bodies governing them.
- Knowledge and experience utilizing research and providing statistical analysis.
- Strong research analytical criticalthinking and problemsolving skills.
- Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results.
- Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry.
- Strong professionalism with customer relations and managing client relationships.
- PC/Technical skills: strongly proficient in MS Office Suite Excel Word PowerPoint.
- Excellent oral and written communication skills and presentation skills.
- Ability to lead a team and mentor junior Regulatory Team members.
- Experience working with CLevel and senior management.
Special Requirements:
- Travel: 10 (to the Companys offices and for meetings/conferences/etc.
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
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. potential base pay range for this role when annualized is $134800.00 $250300.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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 welfare and/or other benefits.
Required Experience:
Director
Employment Type
Full-Time
