Sr Regulatory Affairs Spec

Sr Regulatory Affairs Specialist

HM's Top Needs :

• Experience with assessing product changes for regulatory impact - US, EU
• Good communication skills
• Project Mgmt - will have multiple projects going on at the same time

Education Required : Bachelors

Years’ Experience Required : 4+ years experience with assessing product changes for regulatory impact in US and EU.

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours

Work Location :

hybrid (3 days) from Mansfield, MA office

Senior Regulatory Affairs Specialist

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.

The position will report into the Surgical Regulatory organization.

Operating Unit

Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics.

We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.

We will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of client and the customers and patients we serve.

Day in the Life

Responsibilities include but are not limited to the following :

• RA 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.

Must Have : Minimum Requirements

• Bachelor’s degree with 4 years of regulatory affairs experience
• OR an advanced degree with 2 years of regulatory affairs experience

Nice to Have

• 5+ years of experience in medical device regulatory affairs with roles showing increasing responsibility.
• US and global regulatory affairs knowledge and experience.
• Microsoft Word, Excel and Adobe software skills.
• Experience working with cross-functional teams.
• Experience working with technical documentation / Global Submission Summary documentation.
• Effective verbal and written communication skills both internally and externally.
• Experience with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Work well under pressure in a dynamic environment.
• Highly organized, detail-oriented, and efficient.
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Ability to manage projects to completion within and outside of the direct department and company.
• Strong interpersonal and negotiation / influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• RAPS Regulatory Affairs Certification (RAC).

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