What are the responsibilities and job description for the Regulatory Specialist position at S S WHITE BURS INC?
Description
About SS White:SS White® is a dental manufacturer that has always offered high quality dental products to market, to enable practitioners to work more accurately and precisely, and to maximize comfort and quality for every patient who enters a dental office. We believe that innovation and the creation of unique and differentiated products are the cornerstone of SS White®. 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 project management leadership for medical device regulatory submissions, 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.
Requirements
· 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 risks· Interpret Regulatory Agency requests and correctly apply them as appropriate for assigned devices.· Assess 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 external partners.· Contribute to preparing for external audits and provide support during audits.· 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· Participate in other activities as needed, e.g. post-market surveillance, training, export documentation, document legalization etc Skills/Qualifications:Experience in FDA regulated industry (preferably medical device)Knowledge of ISO 13485 and quality system principlesAbility to apply risk-benefit analysis techniques.Ability to interpret technical documentation.The ability to write and edit technical product documentation Benefits Available SS White offers competitive compensation and comprehensive benefits, including medical/dental/vision insurance, 401(k) plan, life insurance, vacation and personal days, paid holidays and tuition reimbursement. No relocation benefits are available for this position. Visit our website at www.sswhiteburs.com.
Apply by submitting cover letter, salary requirements and resume to hr@sswhiteburs.com
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Regulatory Specialist?
Sign up to receive alerts about other jobs on the Regulatory Specialist career path by checking the boxes next to the positions that interest you.
Demo