For more than 10 consecutive years, A-dec was chosen as one of the top five places to work for in Portland Business Journal’s Oregon’s Most Admired Companies. As the leading dental equipment manufacturer in North America, the reason is simple: we believe in people first.
The Regulatory Compliance Specialist is responsible for the coordination, compilation and maintenance of various compliance activities and records to ensure A-dec products and systems are in compliance with applicable federal and international quality and regulatory requirements. The position provides support for the Quality/Regulatory department and partners across business functions to ensure efficient, compliant business processes and environment.
Identify requirements for new or revised quality system procedures and provide direction for the preparation and control of these documents. Help create, develop, and maintain procedures/records to support compliance with applicable quality/regulatory requirements company wide.
Represent regulatory on various cross-functional teams to ensure compliance with requirements and procedures. Partner with teams, execute tasks, and ensure timely compilation of documents/records.
Prepare, organize, and coordinate content to ensure compliance for product submissions to the FDA, Health Canada, EU, or other regulatory agencies.
Prepare and maintain listings and registrations of medical devices and/or establishments with regulatory agencies.
Manage the internal audit process, lead audit teams, and/or act as lead auditor to conduct ongoing internal audits in all areas of the company to ensure quality systems are functioning effectively in conformance to regulatory requirements. Guide and provide assistance to external auditors during official audits.
Analyze audit results and provide direction for necessary corrective action related to process issues and continuously improve internal audit methods to ensure A-dec quality system standards are maintained.
Gather, prepare and verify timely financial information for Sunshine Act reporting. Submit accurate information to appropriate regulatory agencies.
Research and review information from external sources to stay abreast of regulatory and technical developments in the industry. Evaluate impact to A-dec in order to achieve and maintain regulatory compliance.
Conduct regulatory reviews of customer complaints; assess and record the regulatory reportability decision.
Assist in developing and delivering regulatory training for company employees on a wide variety of regulatory topics. Provide supplemental required training for internal auditors and coordinate professional training as a requisite for new auditors, as needed.
Perform other duties as required.
Minimum 2-4 years of experience in Regulatory Affairs.
Demonstrated working knowledge of federal/international medical device regulations, guidance, and standards (e.g., FDA, CMDR, MDD/MDR, ISO 13485, MDSAP) applicable to A-dec products.
Ability to read, understand and interpret complex laws, standards, rules, and regulations.
Ability to work under minimal supervision and with all levels of the organization.
Must have strong planning and organizational skills with the ability to prioritize work and manage time effectively in both a team environment and as an individual contributor.
Must also show attention to detail and have the ability to concurrently work with multiple deadlines while remaining results oriented.
Must have excellent verbal and written communications skills.
Strong PC skills required, using general office software and database systems.
Occasional travel may be required.
Bachelor’s degree in Biology, Chemistry, Engineering, or Regulatory Affairs with experience working with the FDA, global regulatory agencies or equivalent. Experience in the medical device industry and/or regulatory science industry. Experience following regulatory document and GMP requirements.
A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor”
Additional Salary Information: There is a lot to like about working here! With a people first attitude, A-dec is an empowering workplace focused on total well-being. This includes:
401k, profit sharing and retirement plans
Generous PTO and holidays
Health, dental and vision benefits
Competitive pay and bonuses
Professional development programs
A commitment to excellence, growth and promoting from within
A beautiful campus with an on-site workout program and free parking
An industry leading company with more than 50 years of success
Internal Number: 2019-2547
The A-dec vision began with a simple idea: make the best better.
From our simple beginnings, A-dec has emerged as one of the most respected names in the dental industry. In 1964, founders Ken and Joan Austin made the biggest choice of their lives: risk it all to start a company of their own. Little did they know that an invention and a dream would help revolutionize the world of dentistry.
More than 50 years later, A-dec is an employer of choice and the world’s leading manufacturer of reliable dental operatory equipment. We continue to work for the betterment of dentistry. That’s why we embed our values into the work we do every day. One choice at a time.