Address
Form of workFor over four-decades, North Coast Medical (NCM) has established itself as a global leader in the Occupational, Physical and Hand Therapy markets. We design, manufacture and distribute a broad range of industry-leading product lines. NCM's four functional divisions services the needs domestic healthcare providers, consumers, dealers and international distributors. We are still family-owned, and our founders' original core values of providing opportunities for customers and employees alike remain.
Our team of diverse people, unwaveringly committed to excellence in product development, procurement, delivery and customer service. We value the talents and abilities our employees bring to this company and we believe they are an integral part of what makes us competitive and successful. We don't just accept difference - we celebrate it, we support it and we thrive on it for the benefits of our employees, our products and our community. We are proud to be an equal opportunity workplace.
NCM offers:
Competitive salaries
Excellent benefits (e.g. Medical / Dental / Vision / Life Insurance, PTO, 401k Match, Employee Assistance Program)
And the opportunity to work from home
North Coast Medical is looking for a VP of Quality & Regulatory Compliance. This position will report to the CFO. See more details below!
Position Summary Overview: Responsible for regulatory strategy, oversight and direction. Responsibilities include but are not limited to evaluation, development, and management implementation of company quality systems and processes.
Hours: Full-Time, Exempt
Compensation: $135,000-$150,000
Location: Remote
Essential Functions and Position Responsibilities:
-Provide strategic leadership, oversight & management that supports company objectives
-Responsible for developing and directing strategies, objective and policies
-Provide guidance and support in the resolution of compliance-related issues and challenges
-Conduct training programs to enhance the team's knowledge and skills
-Monitor and assure Regulatory Compliance requirements and commitments
-Collaborate with R&D, manufacturing, operations and other departments to integrate quality and regulatory considerations into all processes
-Act as a liaison between the company and regulatory authorities, representing the organization in regulatory matters
-Direct and contribute to the preparation and submission of regulatory regulatory filings (including 510(k)s, MDRs and other)
-Oversee regulatory affairs in product recall, communication processes, FDA or other regulatory audits
-Act as Management Representative for the US, EU and other international regulatory governing agencies when necessary
-Keep ahead of domestic and international regulatory requirements and changes within the regulatory registration process
-Assure supplies auditing of processes and performance evaluations of approved suppliers
Position Requirements and Qualifications:
-Master's degree in Quality Assurance, Quality Management, Engineering or related field
-15+ years of experience in Regulatory Affairs, Quality Assurance/Quality Control, including the US and International medical device regulations
-Proven record of successful process improvement initiatives, including FDA registrations, pre-sub, 510(k), ISO, CE marks and managing other regulatory matters
-Knowledge of Quality management systems and standards
-Excellent analytical and problem-solving skills
-Strong organizational and communication skills
Physical Requirements and Work Environment:
-This position is primarily remote, but may require travel to the Corporate Office when and if required for certain job functions
-The work involves a combination of sedentary to light work in a home office setting, as well as activities supporting outside sales activities including but not limited to travel and overnight accommodation
-Home office activities will require the frequent need to stand, stoop, walk, sit, lift light objects (up to 10 pounds) and perform other similar actions during course of the workday
-Other required activities include but not limited to frequent speaking, listening using a headset, using both chat and video conferencing. Additionally, sitting, use of hands/fingers across keyboard or mouse for extended periods of time working at a computer
-High speed internet connection with full video conferencing capacity and bandwidth for VPN access
