Job Information
Envista Holdings Corporation Regulatory Affairs Manager in Kloten, Switzerland
Job Description:
Lead development and execution of regulatory strategies for Prosthetics & Digital development projects for market access to EU/UK/CH, US & CA, compliance projects and lifecycle management activities and ensure all RA related elements & requirements are implemented.
Assembling, and ensuring quality of the deliverables related to CE/UKCA marking, 510(k) submissions and Health Canada submissions for Prosthetics & Digital devices and workflows.
Represent the RA function in software integration or digital workflow implementation projects for market access to EU/UK/CH, US & CA.
Provide regulatory input and technical guidance on respective regulatory requirements to project teams.
Revise or create Technical Files and review to ensure they are in compliance with procedures and consistent and that the input documents fulfill regulatory requirements.
Evaluate the regulatory environment and contribute by providing advice throughout the product lifecycle to ensure product compliance.
Evaluate proposed change requests and drive the regulatory implementation of change requests.
Provide regulatory information and guidance for proposed product claims/labeling. Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
Review of labels and IFUs.
Support internal and external audits through audit preparation, audit back-office or in audit front office. Proactively plan and organize audits and ensuring audit team and SMEs are appropriately trained.
Creation and maintenance of regulatory procedures and templates. Identification of updates required for compliance, correctness, interaction or efficiency reasons, as well as need for any new procedures.
#LI-EU1
Job Requirements:
Critical Knowledge and Qualifications:
A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred.
In depth knowledge of core aspects of the medical device quality management systems 21 CFR Part 820, ISO 13485 and MDSAP.
In depth knowledge of core aspects of the MDR including classification, technical file requirements and GSPRCs. Overview knowledge on remaining areas including country specific requirements.
In depth knowledge of core aspects of US and CA regulatory system set-ups, classification methods and submission principles.
Knowledge of core aspects of the design control process requirements and requirements for technical documentation for medical devices.
Critical Skills/technical know-how:
Fluency in English a must. German or further languages is an advantage.
Able to communicate effectively with stakeholders, ensure understanding, alignment on issues questions and goals.
Able to work in teams and to build up a multidisciplinary network. Contribute to building a respectful, diverse and inclusive workplace, where decisions and transactions are transparent and fair.
Able to support decision making process and establish basis for selection of solutions.
Capable to plan out daily work to deliver on time, able to make adjustments when required and prioritizing work.
Critical Experience:
Minimum 4-5 years' experience in regulatory affairs within medical device industry.
Minimum 3 years' experience in working directly with authorities.
Operating Company:
Nobel Biocare
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.
Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .