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Lead Manager of Regulatory Affairs

2 months ago

Lake George, United States COV Covidien LP Full time
Position Overview

As a key member of the team at COV Covidien LP, you will embark on a fulfilling career dedicated to advancing healthcare solutions and ensuring equitable access to medical innovations.

Role Responsibilities
In the capacity of Senior Regulatory Affairs Manager, your primary focus will be to devise and implement strategies for global product approval submissions. You will oversee submission activities, particularly within the US and EU markets, while ensuring compliance for Acute Care and Monitoring products.

Your leadership will be instrumental in achieving results through both direct involvement and delegation to team members. Collaboration with business partners will be essential in formulating regulatory strategies that align with corporate objectives, translating these strategies into actionable plans for the Regulatory Affairs teams.

Key Duties Include:
1. Providing guidance and mentorship to specialists to meet project timelines and resolve operational challenges.
2. Developing comprehensive regulatory strategies for Acute Care and Monitoring products to fulfill business goals.
3. Engaging with external regulatory bodies and cross-functional teams to ensure alignment of regulatory strategies with business objectives.
4. Leading discussions with regulatory agencies to support strategy development and regulatory reviews.
5. Offering insights on regulatory requirements for contingency planning and ensuring adherence to all relevant regulations.

Team Development
Foster a high-performance culture by setting clear expectations for team members, providing constructive feedback, and conducting performance evaluations. Your role will involve supporting the professional growth of team members at various experience levels.

Reporting and Compliance
Regularly report to senior management on progress towards product submission goals and provide regulatory guidance on new product registrations, modifications, and acquisitions. Continuously seek improvements in operational processes and communication pathways to enhance efficiency.

Qualifications
A Bachelor's Degree coupled with a minimum of 7 years of experience in regulatory affairs within the healthcare, medical device, or pharmaceutical sectors, including at least 5 years in a managerial role. Alternatively, an advanced degree with at least 5 years of relevant experience and managerial responsibilities will be considered.

Preferred Skills
A degree in Engineering or an advanced qualification is advantageous. A proven history of leading high-performing teams, extensive knowledge of U.S. and international regulations, and experience with regulatory agencies will be beneficial. Strong problem-solving abilities and effective communication skills are essential.

Physical Requirements
The role requires meeting specific physical demands necessary for performing essential job functions. Reasonable accommodations may be made for individuals with disabilities.

About COV Covidien LP
We are committed to addressing significant health challenges globally through innovative healthcare technologies and solutions.