Coloplast has an exciting opportunity for a Head of Regulatory Affairs to join our North American team.
This position directs the regulatory affairs function to secure/maintain product approvals in assigned geographies and to assure compliance with applicable regulations and corporate requirements. In this role you will be the US Agent and Official Correspondent to the FDA and Health Canada for Coloplast A/S and all associated locations.
Major Areas of Accountability
* Manage the budget, staff, and responsibilities for regulatory affairs including setting, monitoring and maintaining department goals and individual objectives to assure regulatory compliance is maintained. Serve as Official Correspondent to FDA and Health Canada. Serve as US Agent for Coloplast A/S and other Coloplast manufacturing sites. Authorized to CE-mark Skin Care products and interact with notified bodies.
* Manage work assignments for the Regulatory Affairs staff to assure efficient and effective utilization to complete regulatory submissions and maintenance activities to support the business needs. As part of the Regulatory Affairs Group, perform hands on work on a variety of projects as needed.
* Oversee Regulatory Affairs support for the R&D organization through active participation on project teams with development of regulatory deliverables per the project plans and active monitoring of conformance to the design assurance requirements to ensure they meet the intended use and user needs with sufficient documentation to support global regulatory clearance/approval.
* Manage the maintenance activities related to design changes and assure that the documentation is kept current in the design history files with appropriate regulatory applications if needed
* Manage the RA staff training program for assuring understanding of requirements to support compliance with procedures/instructions and applicable regulations.
* Regularly review and maintain as needed corporate and local procedures/instructions to assure ongoing compliance and appropriateness for local needs
* Manage post-market surveillance, adverse event reporting, health hazard evaluation and recall
* Maintain current knowledge of regulations and requirements for relevant product categories in relevant geographies and communicate those within the company and to external partners. Support Coloplast at meetings with FDA and primary contact for audits with Health Canada.
* Direct preparation of regulatory strategies and submission preparation including IDEs, PMAs, 510(k)s, Canadian medical device licenses, Canadian drug identification number applications and Canadian natural health products. Assure that appropriate maintenance of registrations occurs including renewals, device and drug listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
* Participate in recall process for Chronic Care, Wound and Skin Care products in the US. Provide resources to manage execution and communication with authorities for all recalls in the US or Canada.
* Direct design assurance support for the WC R&D organization
* RA support for registrations in emerging markets.
* Co-host external audits by FDA, ISO notified body quality audits, customers or other appropriate agencies. Assist in developing and tracking appropriate corrective action.
* Conforms with Coloplast Code of Conduct and all local Compliance Standards
* Conforms with Coloplast Q/EHS Policy
* ( policy.pdf)
* Other duties as assigned
* 8+ years related experience in medical device industry working with class II and class III medical devices
* 1+ years successful Regulatory Affairs management experience preferred
* Experience and demonstrated application of FDA and ISO quality system requirements.
* Experience and demonstrated application of FDA, Health Canada & EU Regulatory submissions
* MS or BA/ BS degree with equivalent experience & education preferred
* Live in the Minneapolis/ St. Paul, MN Metropolitan area
* Ability to travel including international up to 30%
Required Knowledge, Skills and Abilities
* Demonstrates excellent Project Management skills with the ability to manage multiple projects across interdisciplinary functions (including outside vendors or agencies) and gain consensus/approval where needed
* Ability to lead, manage and support cross-functional/ international projects, prioritize & drive strategic objectives
* Potential and desire in leading, directing and motivating others (experience preferred)
* Strong, inherent values
* Excellent written and verbal communication skills with the ability to listen, articulate and advocate
* Pro-active; high-performance and results orientation. Hands on work in addition to managerial responsibilities in a number of different areas of Regulatory Affairs per business needs.
* Proven ability to support cross-functional and international projects desirable.
* Negotiations skills desirable.
* Must be able to digest complex data while keeping the big picture through good analytical skills.
* Demonstrates both creative and critical thinking skills
* Basic computer (spreadsheet, word processing) skills
* Ability to adapt and willingness to change
* Business acumen and analytical skills
* Open-minded with a global mind set
* Embraces cultural differences within a global organization
* Willingness, ability and desire to learn
* Ability to consistently work, manage and lead with ethical integrity
* Passionate and a team player
* Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals
The job information contained herein will apply to the candidate successful in being hired for the position. If interested, please apply today!
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 10,000 people and with products available in more than 100 countries, we are one of the world?s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
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