Sr. Regulatory Affairs Associate

Position Summary

The Sr Regulatory Affairs (RA) Associate will be responsible for a variety of regulatory activities to meet submission, departmental, and quality system compliance requirements. The Senior RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory deliverables, take primary authorship responsibility for market authorization maintenance activities (e.g., renewals and periodic updates), and lead departmental activities supporting product release, regulatory intelligence, and submission metrics. This position will interact with business unit customers to support global submissions. 

Principal Responsibilities

PRINCIPAL RESPONSIBILITIES:  
•    Support 510(k)s and associated documents, EU MDR submissions, and Health Canada license applications and amendments.
•    Prepare electronic submission compilations for the United States (US), Canada, and EU markets.
•    Update and maintain EU MDR technical files and documentation to ensure continued compliance.
•    Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc.
•    Support regulatory requests for global markets.
•    Update and maintain regulatory trackers, databases, and submission files.
•    Apply understanding of the quality systems to job activities and projects.
•    Update and maintain market authorization and regulatory submission/correspondence files. 
•    Support IPN and GTIN requests.
•    Execute SAP ship control transactions to release, hold, or end product commercialization for the US and Canadian regions.
 
•    Generate trending and metric reports, e.g market authorization review times, change order review times, project time tracking. Maintain submission trackers.
•    Coordinate worldwide submission change notifications and regulatory impact assessments.  Communicate the impact and support required for regulatory activities.
•    Update applicable quality system procedures to ensure continued compliance

Education / Experience Requirements

•    A bachelor’s degree, preferably in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.
•    Minimum 2 years of medical device regulatory experience or equivalent.
•    Basic experience with preparing 510(k) submissions, EU MDR Technical Documentation Files, or Health Canada license applications.
•    Basic experience with change control process and assessments. 
•    Basic experience working with cross-functional teams.

Preferred:
•    Basic medical device global regulatory knowledge base (outside of the US, EU, and Canada): submissions, marketing approvals, licensing, registrations, and renewals.
•    Knowledge and experience with design control, change assessments, labeling requirements, etc. 
•    Experience and knowledge of Quality Systems requirements and processes. 

Specialized Skills / Other Requirements

•    Orientation for detailed work with emphasis on accuracy and completeness.
•    Effective written and oral communication skills.
•    Good organizational and planning skills; drives for results.
•    Effective analytical/problem-solving skills.
•    Good interpersonal skills that include working well in a team environment. 
•    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
•    Ability to work independently and effectively manage and prioritize numerous projects and responsibilities to meet business needs with routine supervision.
•    Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
•    Proficient with Microsoft Office, Adobe Acrobat, Agile, and SAP.

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