Senior Regulatory Affairs Manager
Are you a highly experienced and driven Regulatory Affairs professional looking for your next challenge? Philips is currently seeking a Senior Regulatory Affairs Manager to join our dynamic team. In this role, you will play a critical role in ensuring that our medical devices and healthcare solutions meet all regulatory requirements and standards. We are looking for a strategic and detail-oriented individual with a passion for compliance and a strong track record in the medical device industry. If you are ready to take on a leadership role and help shape the future of healthcare, we want to hear from you!
- Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and guidelines for medical devices and healthcare solutions.
- Conduct thorough research and analysis of global regulatory requirements and changes in the medical device industry to inform strategic decision making.
- Oversee the preparation and submission of regulatory documents to relevant authorities, ensuring accuracy and timeliness.
- Collaborate with cross-functional teams to review and approve product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
- Serve as the primary point of contact for regulatory agencies and other external stakeholders, providing timely and accurate responses to inquiries.
- Monitor and track regulatory submissions and approvals, and communicate updates to internal stakeholders.
- Lead and coach a team of regulatory affairs professionals to effectively manage workload and achieve key objectives.
- Conduct internal audits and provide guidance on compliance matters to ensure adherence to regulatory standards.
- Participate in product development and risk management processes to ensure regulatory compliance throughout the product lifecycle.
- Continuously assess and improve regulatory processes and procedures to optimize efficiency and effectiveness.
- Stay informed of emerging regulatory trends and changes in the medical device industry, and proactively recommend strategies to address potential impacts.
- Represent the company in relevant industry associations and conferences to stay updated on best practices and regulatory developments.
Minimum Of 8-10 Years Of Experience In Regulatory Affairs In The Medical Devices Industry, With At Least 3-5 Years In A Management Or Leadership Role.
In-Depth Knowledge Of Global Regulatory Requirements And Experience Navigating The Regulatory Landscape In Key Markets Such As The Us, Eu, And Asia.
Bachelor's Degree In A Relevant Field, Such As Engineering, Life Sciences, Or Regulatory Affairs. Advanced Degree Preferred.
Proven Track Record Of Successful Regulatory Submissions And Approvals For Medical Devices, Including 510(K), Pma, And Ce Marking.
Strong Leadership And Communication Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Stakeholders. Experience In Managing And Developing A Team Of Regulatory Professionals Is Highly Desired.
Risk Management
Quality Assurance
Global regulations
Regulatory compliance
Medical Devices
Product Registration
Regulatory Strategy
Submission Management
Clinical Evaluation
Labeling Requirements
Post-Market Surveillance
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Regulatory Affairs Manager in Bothell, WA, USA is between $120,000 and $150,000 per year. This can vary depending on factors such as years of experience, specific job responsibilities, and the company or industry in which the individual is employed.
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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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