The Regulatory Affairs Specialist will ensure medical device regulatory requirements are met for marketing of Hu-Friedy products in local and strategic international markets Further, this role provides strong product management leadership for medical device regulatory projects, registrations, and internal policy and procedures needed for compliance to international standards and regulations. Internally, this position interacts with all functions (e.g. engineering, quality, sales, marketing, procurement and manufacturing) and will work with all levels (e.g. management and support staff). Externally, this position interacts with regulatory agencies, distributors, consultants, customers, partners, and vendors.
Manage regulatory files and databases to ensure prompt and accurate access to regulatory information and provide reports to Management concerning current, pending, and future registration activities.*
Prepare and assemble documentation for product or facility registrations in local or international markets, as requested.*
Develop and recommend strategies for earliest possible approvals of device applications.*
Assess impact of documentation delays, and where appropriate, recommend contingency plans and strategies to mitigate regulatory or project risks.*
Interpret Regulatory Agency requests and correctly apply them as appropriate for assigned devices.*
Research new and/or modified standards, regulations / laws and determine applicability to the organization and/or product.
Ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements.*
Work effectively with cross-functional staff across multiple sites as well as global external partners.
Contribute to preparing for external audits. Monitor/track open non-conformances/observations from internal and external audits as assigned.
Review change requests for packaging, literature, work instructions/procedures, production BOM/routers and other controlled document for regulatory compliance.*
Represent the regulatory function for new product development projects, as assigned.
Provide support during facility inspections by external parties (FDA, ISO, MDSAP, etc…)
Delegate tasks and assist in training other document control or regulatory staff within the department, as needed.
Participate in other activities as needed, e.g. post-market surveillance, training, export documentation, etc..
Participate in professional associations, industry/ trade groups (local/regional/international) and appropriate
Ensure documents are certified and legalized or notarized, as required.
This position requires an individual with:
Minimum of 3 to 5 years of relevant regulatory experience in the medical device industry with increasing scope of responsibility.
BA/BS degree in life sciences, engineering or related field.
Strong project management skills and experience.
Must be proficient with Microsoft Word, Excel, Project and SharePoint.
Experience working with ISO 13485 quality system principles and practices.
Experience and knowledge with domestic and international laws, regulations, and guidance that affect medical devices.
The ability to independently research, learn and manage implementation of regulatory requirements for additional international markets.
The ability to write and edit technical product documentation.
The ability to apply risk-benefit analysis techniques.
Translate and communicate technical regulatory issues for nontechnical audiences.
Ability to raise issues with colleagues and managers in a proactive, professional manner and drive win-win outcomes.
The ability to participate in training as a trainer or trainee either on or off site.
Multilingual is a plus, Spanish highly preferred.
RAC accreditation (through RAPS) is a plus.
The ability to travel up to 10% of working days is required.
Hu-Friedy is an Equal Opportunity/Affirmative Action employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other protected characteristic. The EEO is the Law poster is available here .
Internal Number: 18.78
About Hu-Friedy Manufacturing Company
Founded in Chicago in 1908, Hu-Friedy Manufacturing Company helps dental professionals perform at their best by producing dental instruments designed to function as an extension of each practitioner's particular skill. Its products, hand-crafted by highly-skilled artisans, are known for their precision, performance, longevity, reliability and quality. Hu-Friedy products are distributed in more than 75 countries, and the Company has offices in Frankfurt, Milan, Shanghai and Tokyo. For further information, please visit our website at http://www.hu-friedy.com.