Sr Regulatory Affairs Specialist

Job Summary:The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for medical device registration and compliance, with a focus on European Medical Device registration. The candidate must have successfully demonstrated technical proficiency, creativity, initiative, independent thinking, and collaboration with others.Essential Job Duties and Responsibilities:Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files in accordance with MDD and MDR.Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR).Ensure compliance with US and international regulations and guidelines. Provides routine regulatory support, which may include, but not limited to:Support the compilation, development, submission, and maintenance of worldwide regulatory filings;Track regulatory project status and informational documents;Create timelines and track deliverables to timelines to ensure that all submissions are submitted on time;Interface with global Regulatory partners and internal cross-functional teams; and,Attend relevant functional area and project team meetings as required.Other duties as assigned.Education, Experience, Skills, & Abilities:• Senior Regulatory Affairs professional with a minimum of 5-10 years of experience authoring medical device Technical Files, in accordance with MDD, successfully approved by European Notified Body for CE marking. Must be able to work independently with minimum direction from supervisor. Must have experience in label review/approval for CE marking. Must be knowledgeable in MDR requirements. Experience in the dental field is a plus.• Bachelor’s Degree in biology, chemistry, biochemistry, microbiology, or related discipline. • Experience with the use of spreadsheets, word processing, and database application software (i.e. Excel, Adobe, Word).• Flexibility and agility to accommodate project changes and time constraints.• Ability to work in collaborative and independent work situations with minimal supervision.• Demonstrated interest and capability in learning subject matter and processes.• Demonstrated ability to solve problems with limited supervision.• Demonstrated effective interpersonal, teamwork, and communication skills required.• Ability to use Regulatory information systems.Physical Requirements:Ability to sit, use hands and fingers, talk or hear, and smell continually. Ability to stand, walk, and reach frequently. Ability to climb or balance, stoop, kneel, or crouch occasionally.Ability to frequently lift and carry up to 10 lbs. and occasionally lift and carry up to 25 lbs.Close vision is required to use a microscope, read documents, and operate a machine. Distance vision is required to drive an automobile if driving is a requirement of the job.Work environment is indoors and climate-controlled. Occasionally exposed to outdoor weather conditions.Moderate noise levels as found in a light industrial environment, office environment, households with TVs and dishwashers, and driving light traffic. Employee Acknowledgement:The above job description is intended to describe the content and requirements for this job's performance. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Zest Anchors reserves the right to change, add, or delete at any time from this job description to meet the needs of the Company.