Senior Regulatory Affairs Manager- REMOTE

Revvity • Boston, MA

118d • $140,000 - $150,000 • Remote

About The Position

Supports North America Regulatory activities. Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs. Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements. Develop North America regulatory strategies plan for submission for IVD products. Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment. Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products. Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business. Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated. Support CE marking activities for IVD products and other market clearance for products manufactured globally. Review and approve promotional materials and product labeling. Support importation/exportation permitting activities. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.

Requirements

• Bachelor's Degree in a STEM field and 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) OR Master's or PhD degree in a STEM field and 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions).

Nice To Haves

• Travel as circumstances dictate.
• Excellent understanding of regulations and guidance documents required in Americas region.
• RAC certified.
• Excellent interpersonal, verbal and written communication skills (in English).
• Excellent time management, organizational, negotiation, and problem-solving skills.
• Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management.

Responsibilities

• Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices.
• Participate on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements.
• Develop North America regulatory strategies plan for submission for IVD products.
• Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment.
• Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products.
• Maintain up-to-date knowledge of IVD regulations and applicable guidance.
• Monitor development of regulations and communicate impact to the business.
• Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated.
• Support CE marking activities for IVD products and other market clearance for products manufactured globally.
• Review and approve promotional materials and product labeling.
• Support importation/exportation permitting activities.

Benefits

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• Compassionate Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree