Senior Regulatory Affairs Specialist
3 weeks ago
Senior Regulatory Affairs Specialist
Location: Mansfield, MA (Preference), with possible consideration for North Haven, CT, and Lafayette, CO.
Hybrid Role: 3 days a week
Target Pay Rate: $50-61/hr.
Weekly Hours: 40 hours
Overview:
As a Senior Regulatory Affairs Specialist, you will play a key role in planning and executing regulatory strategies for molding and capital tooling projects. You will assess the regulatory impact of post-marketing changes and lead project teams through complex regulatory requirements. This role is part of our Surgical Regulatory organization within the Surgical Operating Unit.
Key Responsibilities:
- Act as the Regulatory Affairs representative on project teams.
- Plan and execute regulatory strategies for molding and capital tooling projects.
- Assess regulatory impacts of post-market changes.
- Create and manage all materials necessary for project deliverables.
- Ensure compliance with multiple Quality Management Systems.
- Stay updated on regulatory procedures and changes.
- Manage and execute projects while adhering to time schedules and regulatory standards.
Top Qualifications:
- Bachelor’s degree with at least 4 years of experience in regulatory affairs, or an advanced degree with a minimum of 2 years of experience.
- Experience in assessing product changes for regulatory impact in the US and EU.
- Strong communication skills and project management abilities.
- Proven experience in working with cross-functional teams and technical documentation.
Preferred Qualifications:
- 5+ years of experience in medical device regulatory affairs with increasing responsibility.
- Knowledge of US and global regulatory affairs.
- Proficiency in Microsoft Word, Excel, and Adobe software.
- Experience with regulatory documentation and global submission summaries.
- Effective verbal and written communication skills.
- Problem-solving and project management experience.
- Strong organizational skills, attention to detail, and ability to work under pressure.
- RAPS Regulatory Affairs Certification (RAC) is a plus.
About Us:
Our Surgical Operating Unit unites the people and products of Surgical Innovations and Surgical Robotics, allowing us to leverage our global commercial capabilities and deliver innovative solutions. We are committed to advancing surgical solutions and offering career growth opportunities within a dynamic and supportive environment.
Career Growth:
We offer award-winning programs designed to accelerate your professional development. Our expansive scope and market leadership provide ample opportunities for career exploration and growth.
Day in the Life:
Expect a role that demands initiative, adaptability, and the ability to manage complex projects. You will be working in a collaborative team environment, contributing to the success of our regulatory affairs strategies.
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