Job Description Working closely with the Global Regulatory Affairs team, you'll be responsible for planning, scheduling, and managing the preparation and submission of regulatory applications to local authorities, including support for EU MDR submissions and approvals. Ensure all marketed devices secure and maintain necessary regulatory approvals, managing registration processes according to both regulatory guidelines and internal company procedures. Proactively maintain an up-to-date project tracker, ensuring all information is current and accurate. Collaboration with the Business Manager and Dealers is crucial to identify and mitigate potential supply chain risks Completes other regulatory activities as assigned by Department Head. Job Requirements Critical Skills Graduate / Postgraduate preferably in Life Sciences or equivalent. 3-5 years Industry Experience in Regulatory Affairs, preferably in medical devices. Knowledge and competency in application of Local regulations D&C Act and Rules, MDR 2017 Good spoken and written of English language. Proficient in the use of MS Word, Excel and PowerPoint Other desired skills: Able to work independently and possess great sense of responsibility, accountability and Highly motivated to take ownership, adaptable to change, and receptive to innovative approaches. Proficient in the use of MS Word, Excel and PowerPoint. Fostering collaboration with key stakeholders. Possesses strong project management skills. Good working attitude. Critical thinking and problem-solving. Strong communication skills. Operating Company Kerr 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. Show more Show less
Job Description JOB SUMMARY: The Regulatory Affairs (RA) Specialist is responsible for supporting the Regulatory Affairs department in global submissions, registrations, approvals, and audits; especially as it relates to footprints projects and sustaining activities. This is a great learning opportunity for someone interested in a Regulatory Affairs career in medical devices. Will train an enthusiastic, eager learner with a team attitude and passion for medical devices and helping patients thrive. Primary Duties & Responsibilities Supports footprints projects with the ability to multi-task Assembles and submits documents for global registrations with direct oversight from the RA team Ensures all deadlines are met, paying particular attention to any government deadlines Collaborates with other departments to gather documentation needed for global submissions Responds effectively and timely to internal and external partners Tracks submissions and maintains applicable dashboards Prepares weekly reports on status of current items/issues to manager Organizes and maintains files, folders and databases to support the integrity of regulatory documentation Orders documents, subscriptions, articles, standards and other items; including Free Sale Certificates and Certificates to Foreign Government Coordinates audits as needed Coordinates notarization and authentication (legalization) of documents Coordinates shipment of documents (UPS, etc.) and may also be responsible in coordinating samples Prepares data for audits, as needed Reviews publications to keep abreast of regulatory landscape for medical devices Performs special projects at the direction of the Regulatory Affairs Management May assist in the regulatory review of product claims and literature Job Requirements REQUIREMENTS: Bachelor’s degree in a related field plus 2 years of relevant work experience required, preferably in the Medical Device or Pharmaceutical industry or technical field. Operating Company Kerr 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.