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Remote Sr Regulatory Affairs Spec

Mansfield, MA 02048

Posted: 09/20/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614292 Is job remote?: Yes Country: United States

Job Description


HM's Top Needs:
  1. Experience with assessing product changes for regulatory impact - US, EU

  2. Good communication skills
  3. 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.


    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.

 

With the company Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of the compnay and the customers and patients we serve. 

 

Careers That Change Lives

Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. This company offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities — and grow as we grow.

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).

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Mansfield, MA

Ready to embark on your next career adventure in Mansfield, Massachusetts? Explore our job opportunities in this vibrant town filled with charm and growth potential. Nestled between Providence, Rhode Island, and Boston, Massachusetts, Mansfield offers a perfect balance of small-town charm and big-city opportunities. Enjoy live music at the Xfinity Center, catch a game at Gillette Stadium, or hike the trails at the nearby Borderland State Park. With a rich history, delicious seafood cuisine, and a thriving arts scene including the Mansfield Music and Arts Society, this area provides an enchanting backdrop for your career journey. Discover the perfect job match in Mansfield today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.