Regional Regulatory Specialist

Job Description

Job Description: Working closely with the Global Regulatory Affairs team, youll 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 Hea d. 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 Envistas 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.