
Senior Regulatory Project Manager
Are you a highly motivated and detail-oriented individual looking for an exciting opportunity to lead and drive regulatory projects within a global healthcare organization? Look no further, as Philips is seeking a Senior Regulatory Project Manager to join our team. As the leader of our regulatory project teams, you will be instrumental in ensuring compliance with all regulatory requirements for our medical devices and products. We are looking for a dynamic individual with a strong background in regulatory affairs, project management, and leadership skills to join our team. Are you up for the challenge? Read on to learn more about the qualifications and responsibilities for this role.
- Lead and manage regulatory projects for medical devices and products within a global healthcare organization.
- Ensure compliance with all regulatory requirements and standards.
- Develop and maintain project timelines, budgets, and resources.
- Coordinate and collaborate with cross-functional teams to ensure timely and successful completion of projects.
- Conduct risk assessments and develop mitigation strategies for potential regulatory issues.
- Keep abreast of changes in regulatory requirements and communicate updates to relevant stakeholders.
- Develop and implement regulatory strategies for new product development and market entry.
- Prepare and submit regulatory submissions to health authorities.
- Act as the primary point of contact for all regulatory agencies and maintain positive relationships.
- Provide guidance and support to project team members on regulatory matters.
- Conduct internal audits and ensure adherence to regulatory standards.
- Mentor and coach team members on regulatory processes and procedures.
- Communicate project progress and escalate any issues or delays to senior management.
- Ensure all project documentation is accurate, complete, and maintained in accordance with regulatory requirements.
- Participate in continuous improvement initiatives to streamline regulatory processes.
Minimum Of 7 Years Of Experience In Regulatory Affairs, Preferably In The Medical Device Industry.
In-Depth Knowledge Of Global Medical Device Regulations And Standards, Including Fda, Eu Mdr, And Iso Requirements.
Proven Track Record Of Successfully Managing And Leading Regulatory Projects From Start To Finish.
Strong Leadership Skills With The Ability To Effectively Communicate And Collaborate With Cross-Functional Teams.
Bachelor's Degree In A Related Field, Such As Engineering, Life Sciences, Or Regulatory Affairs. A Master's Degree Is Preferred.
Quality Assurance
Strategic Planning
Project Management
Budget management
Leadership
Risk assessment
Regulatory compliance
FDA regulations
Stakeholder management
Cross-Functional Collaboration
Medical
Regulatory Strategy
Communication
Conflict Resolution
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Regulatory Project Manager in Nashville, TN, USA is $110,000-$160,000 per year. This range may vary depending on the specific industry, company, and level of experience of the individual.
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Royal Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

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