Principal Regulatory Affairs Specialist
Welcome to Boston Scientific, a company dedicated to transforming lives through innovative medical technology. We are currently seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our team. This role offers the opportunity to make a significant impact on the development and distribution of life-saving products around the world. As a Principal Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with global regulations and standards, and will have the opportunity to collaborate with cross-functional teams to bring cutting-edge products to market. We are seeking a detail-oriented and strategic individual with a strong background in regulatory affairs and a passion for improving patient outcomes. If you are a driven and dynamic professional looking for a challenging and rewarding career, we invite you to apply for this exciting opportunity.
- Ensure compliance with global regulations and standards for all products developed and distributed by Boston Scientific.
- Collaborate with cross-functional teams to develop and execute regulatory strategies for new products.
- Stay up-to-date on changes and updates to regulatory requirements and adjust strategies accordingly.
- Lead the preparation and submission of regulatory documents to obtain approvals for new products.
- Conduct risk assessments and provide guidance on potential regulatory issues.
- Review and approve labeling, promotional materials, and product changes to ensure compliance with regulations.
- Participate in audits and inspections by regulatory agencies, and provide support in addressing any findings or issues.
- Communicate with regulatory agencies and respond to inquiries or requests for information.
- Train and educate internal teams on regulatory requirements and changes.
- Monitor and track product registrations and licenses to ensure timely renewals.
- Provide guidance and support to product development teams on regulatory requirements throughout the product life cycle.
- Collaborate with international regulatory affairs teams to ensure global consistency in regulatory strategies and submissions.
Advanced Knowledge Of Regulatory Requirements: The Ideal Candidate Should Possess A Strong Understanding Of Global Regulatory Requirements And Guidelines, Including Fda Regulations, Iso Standards, And Other Relevant Regulations.
Extensive Experience In Medical Device Industry: A Minimum Of 8-10 Years Of Experience In Regulatory Affairs Within The Medical Device Industry Is Typically Required For A Principal Regulatory Affairs Specialist Role. This Experience Should Include Working With Class Iii Medical Devices And Experience In Regulatory Submissions And Approvals.
Strong Communication And Interpersonal Skills: As A Principal Regulatory Affairs Specialist, You Will Be Interacting With Cross-Functional Teams, Regulatory Agencies, And Other Stakeholders. Excellent Communication And Interpersonal Skills Are Essential For Effectively Managing These Relationships And Ensuring Successful Outcomes.
Project Management Skills: This Role Requires The Ability To Manage Multiple Projects Simultaneously, Prioritize Tasks, And Meet Deadlines. The Ideal Candidate Should Have Proven Project Management Skills And The Ability To Drive Projects To Completion Successfully.
Leadership And Strategic Thinking: As A Principal Regulatory Affairs Specialist, You Will Be Responsible For Providing Strategic Direction And Leadership In Regulatory Affairs. The Ideal Candidate Should Possess Strong Leadership Skills And The Ability To Think Strategically To Drive The Company's Regulatory Goals And Objectives.
Risk Management
Quality Assurance
Project Management
Technical Writing
Regulatory compliance
FDA regulations
Medical Devices
Clinical Trials
Labeling Requirements
Post-Market Surveillance
Global Registrations
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist in Marlborough, MA, USA is $120,000 to $150,000 per year. This may vary based on factors such as experience, education, and specific job responsibilities.
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Boston Scientific Corp. engages in the development, manufacture and marketing of medical devices that are used in interventional medical specialties. Its products and technologies are used to diagnose or treat medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health and chronic pain conditions.
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