Director of Regulatory and Quality Systems

SUMMARY

WilMarc is a rapidly growing medical device company which is looking for an experienced Regulatory/Quality professional.  This role will function as a lead member of the management team identifying and developing new product platforms and product lifecycle strategies with direct responsibility to increase sales and market share of emerging products. 

ESSENTIAL FUNCTIONS

This role encompasses all levels of regulatory and quality system engagement from a concept to post-market lifecycle management.  The ideal candidate shall have strong leadership skills to work in a very collaborative environment and the ability to lead, grow and mentor a team of individuals to achieve the defined corporate objectives.

• Participate as a Management Team member driving the growth and direction of the company.
• Overall responsibility for leading all aspects of global regulatory affairs and quality systems for the business.
• Manage all aspects of regulatory and quality strategy development, including the preparation and submission of required documentation (510(k)s, PMAs, CE Product Certifications, Design Dossiers, International Licenses, etc.) to regulatory agencies (U.S. FDA, Health Canada, EU, Japan MHLW, etc.,) to obtain clearance and/or approval.
• Organize efforts and serve as key contact in support facility inspections by regulatory agencies (U.S. FDA, Health Canada, EU, Japan MHLW, etc.,).
• Provide regulatory affairs and quality assurance guidance to all functional organizations, while collaborating closely with other Executive Management Team Members to define the strategic direction of the organization to drive business growth.
• Maintain excellent relationships with regulatory agencies, subcontractors, and providers of non-clinical and clinical studies.
• Oversee and assist in the review and approvals of product packaging and labeling and Sales and Marketing promotional materials.
• Identify relevant quality standards for product development and manufacturing, including appropriate design requirements for domestic and international markets.
• Ensure the company is in full compliance with appropriate global regulations, including appropriate notifications regarding significant changes to product and/or QMS.
• Promote the development of a facility-wide understanding of the key elements related to quality system and regulatory compliance requirements.
• Maintenance of the quality system and associated training that is required.
• Supplier quality program development and maintenance.
• Effectively lead and manage department regulatory and quality personnel.

EDUCATION REQUIREMENTS

• Bachelor of arts or Bachelor of Science preferably life sciences, biomedical, or other engineering science.
• Masters or PhD a plus; auditor qualifications a plus.

POSITION REQUIREMENTS

• 5 to 10 years’ experience in successful pre-market submissions for domestic and international markets.

• Strong technical background in devices/applications highly desirable.  Ability to think ‘out of the box’ and create novel solutions to challenging problems is an absolute necessity.  The successful candidate must work well in team settings and also be able to work independently to ensure completion of time critical projects.
• Proven track record of supporting clinical efforts; demonstrated record of managing collaborators and projects; demonstrated record of working on project teams and multitasking.
• Current knowledge of current U.S. and international regulations and guidelines.
• Hands on quality engineering skills a must.
• Excellent interpersonal and leadership skills; self-motivated and flexible to changing schedules.
• Strong attention to detail, good oral and written communication skills.
• Strong computer skills, including word processing, spreadsheet and data programs.

POSITION COMPETENCIES

• Business Acumen
• Communication Proficiency
• Customer Focus
• Leadership
• Presentation Skills
• Problem Solving/Analysis skills
• Strategic Thinking
• Results Driven

SUPERVISORY RESPONSIBILITY

This position manages all employees of the department and is responsible for the performance management and hiring of the employees within that department.  Executive management reserves the right to require approvals upon any new hire offer.

TRAVEL

Travel of up to 10% may be required during peak business cycles.