Regulatory Affairs Global Program Manager

This position is responsible for strategic process improvement activities related to internal Coloplast processes, as well as evolving FDA, Health Canada, European Union, and other Regulatory Agency requirements across all relevant geographies. This position also supports the Regulatory Function to secure/maintain product approvals in assigned geographies and to assure compliance with applicable regulations and corporate requirements.

Major Areas of Accountability

• Perform Global Regulatory Affairs strategic process improvement activities related to internal IU Coloplast processes (France & US), as well as evolving FDA, Health Canada, European Union, and other Regulatory Agency requirements across all relevant geographies.
• Support RA Senior Director through active participations on Global RA processes involving RA Corporate teams.
• Perform Regulatory Affairs activities to assure efficient and effective regulatory submissions and maintenance activities support the business needs.  As part of the Regulatory Affairs Group, perform hands on work on a variety of projects as needed.
• Support Global innovation teams through active participation on project teams including but not limited to: Identify and complete regulatory deliverables per the project plans; monitor conformance to design requirements ensuring they meet the intended use and user needs with appropriate documentation to support global regulatory clearance/approval. 
• Support new products, maintenance activities, changes, and assure documentation is kept current in the design history files with appropriate regulatory action as needed.
• Regularly review and maintain corporate and local procedures/instructions to ensure regulatory compliance... Ensure Regulatory files are maintained appropriately.
• Manage post-market surveillance, adverse event reporting, health hazard evaluation and recall on relevant projects
• Maintain current knowledge of regulations and requirements for relevant product categories in relevant geographies and communicate those within Regulatory Affairs group and other relevant functions within Interventional Urology (IU) Business.
• Prepare/support regulatory strategies and submissions including IDEs, PMAs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, and other geographies as required on IU products.
• Mentor junior Regulatory personnel: assessing product/process changes; communications with Regulatory Agencies; submissions; labelling; Advertising and Promotion; maintenance of registrations including renewals, device listings, site registrations, supplements for changes and annual reports.
• Provide Regulatory due diligence for potential investment and acquisition opportunities.
• Actively support external audits by FDA, ISO notified body quality audits, customers or other appropriate agencies.  Assist in developing and tracking appropriate corrective action.
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conform with Coloplast Q/EHS Policy
• Other duties as assigned

Competencies

• Applies in-depth knowledge in one job family or broader expertise in most areas of a job function
• Develops solutions to complex problems that require the regular use of ingenuity and creativity. Ensures that solutions are consistent with organization objectives
• Work is performed without appreciable direction. Exercises considerable latitude in determining deliverables of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results. May provide guidance about work activities to colleagues
• Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. Failure to obtain results or erroneous decisions or recommendations would typically result in serious impact on customers and/or results and considerable expenditure of resources
• Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs. Leads briefings with internal and external contacts

Basic Qualifications

• 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

• Excellent demonstrates 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
• 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
• Organizational, 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