Description:The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and projectmanagement activities required for medical device registration and compliance, with a focus onEuropean Medical Device registration. The candidate must have successfully demonstrated technicalproficiency, creativity, initiative, independent thinking, and collaboration with others.Responsibilities:● Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files inaccordance with MDD and MDR.● Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with thenew 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 worldwideregulatory filings;● Track regulatory project status and informational documents;● Create timelines and track deliverables to timelines to ensure that all submissions aresubmitted on time;● Interface with global Regulatory partners and internal cross-functional teams; and,● Attend relevant functional area and project team meetings as required.Skills:MDR, Regulatory affairs, Medical device, Dental, European Medical Device, submissions, Regulatory documentsAdditional Skills & Qualifications: Senior Regulatory Affairs professional with a minimum of 5-10 years of experience authoringmedical device Technical Files, in accordance with MDD, successfully approved by EuropeanNotified Body for CE marking. Must be able to work independently with minimum directionfrom supervisor. Must have experience in label review/approval for CE marking. Must beknowledgeable 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.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.