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Senior Regulatory Affairs Specialist
2 months ago
Title: Senior Regulatory Affairs Specialist
Location: Hybrid in Mansfield, MA
Schedule: 40 hours/week
Position Summary:
In this exciting role as a Senior Regulatory Affair Specialist, you will have responsibility for planning and executing regulatory strategy for molding and capital tooling projects, assessing the regulatory impact of post-marketing changes, as well as leading project teams through the regulatory requirements.
Responsibilities:
+ Will serve as Regulatory Affairs representative on project teams.
+ Planning and executing regulatory strategy for molding & capital tooling projects.
+ Performing regulatory assessment for post-market changes.
+ Creates/manages all materials required to support project deliverables.
+ Monitors and remains in compliance with multiple Quality Management Systems.
+ Keeps abreast of regulatory procedures and changes.
Additional Skills & Qualifications:
+ Bachelor's Degree with 4 years' experience in Regulatory Affairs; OR advanced degree with 2+ years' experience in Regulatory Affairs
+ Must have 4+ years' experience with assessing product changes for regulatory impact in US and EU
+ Must have project management experience
+ US and global regulatory affairs knowledge and experience
+ Experience working with cross-functional teams
+ Experience working with technical documentation/Global Submission Summary documentation
+ RAPS Regulatory Affairs Certification (RAC) is a plus
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
