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Premier Dental Manufacturer in Suffolk County, Long Island is seeking a Regulatory Affairs Specialist to join our Regulatory Affairs & Quality Assurance Department.
Founded in 1948, Parkell continues to manufacture a variety of high quality, top performing dental devices and materials. World renowned for flagship products such as Blu-Mousse®, Cinch®, Dryz® and cutting edge products such as The TurboVue®, Sensimatic™, TurboSENSOR™, Burnett Power-Tip™ and so much more, the company remains as one of the top choices for clinicians who look for well-built, reliable products for their practices. In 2016 Parkell joined forces with Directa Dental of Sweden. Having the same business philosophies of manufacturing solid products and providing outstanding customer care, the merger of Directa AB and Parkell seemed nothing less than the right decision.
Join the Parkell/Directa team and be a part of the excitement
The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and to the Food and Drug Administration (FDA) for class II products. This position entails development of FDA submissions, CE Technical Files and Clinical Evaluations, requiring working knowledge of products under review and of relevant regulations and guidance documents. This position will report to the Quality & Regulatory Affairs Manager.
Work with Product Development, Quality Assurance, and Management to prepare, review and maintain international Regulatory submissions, including CE Technical Files and Design Control documents, and other international filings, to obtain and maintain market access.
Obtain timely market access for products in parallel with US submissions.
Create and submit documents and timely responses with international Regulatory bodies, in accordance with local and international regulations.
Support QA/RA Manager in QMS activities: internal auditor, CAPA system, Complaints, and SOP revisions.
Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations.
Creation, review, and submission of product files for foreign market registration.
Review design changes and technical files for updates to documentation.
Ensure conformance to ISO, CE, FDA and other international/local regulations.
Qualification: Education - Experience
BS degree in Chemistry, Electrical Engineering or health or science-related field. Engineering degree is a plus.
Minimum of 4 years experience in the medical device industry.
Minimum of 2 years experience in International Regulatory Affairs for the medical device industry. Ideally, have knowledge of requirements in accordance with FDA, MDD/MDR, International standards (ISO 13485), MDSAP, and guidance documents (MEDDEVs).
Qualifications: Knowledge, Skills and Abilities Required
Self-starter with excellent ability to work independently with little oversight, as well as excellent organizational, planning, and follow-up skills.
Excellent verbal and written communication skills.
Strong attention to detail.
Desire for continued learning and strength in exhibiting a positive attitude.
Strength in prioritizing and handling several projects concurrently and in meeting strict deadlines.
Ability to work effectively in a team environment and communicate with team members and customers at all levels of the organization.
Proven problem-solving skills.
Ability to take ownership of her/his responsibilities.
Ability to maintain confidentiality in dealing with regulatory and clinical documentation.
Strong technical system skills (e.g. word documents, spreadsheets, online research)
Commensurate with experience. Only resumes with cover letters and salary requirements will be considered.
Competitive compensation package and benefits including excellent health & dental coverage and pension plan. Email firstname.lastname@example.org or fax to 631-389-1595 your cover letter, resume and salary requirements. No phone calls please. Only resumes with cover letters and salary requirements will be considered.
Parkell is an EOE.
"Solutions for the Problem-Solving Dental Professional Since 1948"
Additional Salary Information: Commensurate with experience
Internal Number: 1
About Parkell Inc.
Parkell designs, manufactures, and distributes Dental devices and Materials.