Regulatory Submission Manager

Purpose 

As a key member of the PerkinElmer Life and Analytical Sciences team providing global leadership for regulatory and quality systems compliance, the position is responsible for researching and defining regulatory submission requirements and coordinating with Centers of Excellence regarding medical device submissions.  The incumbent will be expected to become intimately familiar with the technologies and clinical utilities of all assays assigned.  The position also is responsible for performing review of advertising and promotions to ensure such are compliant, especially regards North America.

 Key Responsibilities

Reporting to the Director of Regulatory Compliance, the Regulatory Submission Manager is responsible for researching and defining regulatory requirements for North American medical device offerings / submissions. The incumbent will:

?  Assess regulatory requirements and execute regulatory strategies for obtaining timely regulatory approvals to include considerations such as reimbursement and CLIA.

?  Provide input to intended use and indications for use.

?  Prepare or coordinate US FDA 510k, IDE, PMA and export submissions as required.

?  Ensure that all submissions are accurate, timely, and arguments presented in the submission are appropriate, defendable and scientifically based.

?  Participate in product development/line extension teams to ensure that the product is in compliance with all internal and external regulatory requirements.

?  Provide regulatory support for market-released products as necessary. 

?  Recognize and communicate potential regulatory issues that involve product development through the manufacturing process.

?  Research and communicate evolving / new regulatory requirements to management.  Comment to regulatory agencies as appropriate and as assigned.

?  Monitor the PerkinElmer website for product claims and regulatory compliance with regard to registration and consistency with established product intended use(s).

 Critical Success Factors 

 

?  Technical Skills:  Four-year bachelor?s degree in biological, medical, or engineering disciplione.  Minimum 5 years of regulatory submissions experience and 5-8 years of related medical device experience.  Must have demonstrated proficiency with North American medical device regulations and knowledge of the clinical application of Medical Devices and Medical Device testing methods and statistics.  RAC Certificaiton is highly desired. 

?  Leadership Skills:  Must be able to consistently demonstrate the behaviors required by the PKI Leadership Values listed below.  Must have the ability to work closely with other personnel/departments in providing strong leadership with internal regulatory services and in collaborating efforts, particularly with Marketing & Sales, Research and Development, and Quality Assurance

?  Communication Skills:  Excellent communication skills including verbal, written and personal computing skills.  Effectively communicates with and engages all levels of the organization verbally and in writing; translates technical decisions/strategies into business terms and implications; produces clear, understandable documentation geared for all audiences.

?  Management of Resources:  High level of research, analytical, problem solving, strong attention to detail and project management skills.  Allocates time and resources efficiently, focusing on ever-shifting priorities; continually seeks way to improve individual/team efficiency.  Demonstrates ability to be effective within a matrix environment.

?  Business & Organization Knowledge:  Understands the PerkinElmer business and the impact of the Legal & Intellectual Property organization on the operation. 

 

? Change Management:  Exhibits an assertive personality with a strong bias for action with a results-orientation; tackles tough problems with firm deadlines.