Senior Regulatory Affairs Manager- REMOTE

• 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.

Basic Qualifications:

• Bachelor's Degree in a STEM field

• 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

• 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions)

Preferred Qualifications:

• ​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

Compensation range:

The annual base salary range for this full-time position is $140-150,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. 

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

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What do we offer?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our 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

Learn more about Revvity’s benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.

For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.