Regulatory Affairs Specialist

Job description

Regulatory Affairs Specialist Business Unit: Draeger Medical Systems, Inc., Job-ID: 1284 Location: Andover Function: Quality Work Location: Hybrid Employment Type: Permanent The Job Responsibilities The Regulatory Affairs Specialist will work hybrid in our Andover, MA office. The Regulatory Affairs Specialist will develop the basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures. This position will work with supervision to ensure continued market assess and ongoing regulatory compliance of the Draeger Patient Monitoring device portfolio in US and international markets. This position will support the gathering of regulatory intelligence to assist in the development of local, regional, and global regulatory strategies, and will support the execution of post market product lifecycle management. Develops regulatory strategies by; Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Assessment of options and milestones to de-risk development programs and align with current regulatory requirements and agency guidance. Documenting path(s) to regulatory approval in the Regulatory Affairs Plan (RAP) Developing clear rationales for Letter-to-File (LTF) for product changes that will not impact product approvals or clearances Responsible for: The procurement, assembly, and packaging of the required deliverables for the submission of product registration and approval information as appropriate. Preparation and submission of regulatory documentation according to applicable regulatory requirements and guidelines Communication and interaction with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools. Review labeling and marketing literatures for compliance with regulatory requirements. Responsible for providing product support in preparing US and non-US product submissions (510(k), Technical files, Canadian Licenses and International Registrations), by assessing the acceptability of quality, preclinical, and clinical documents in regulatory submissions to ensure compliance with applicable regulations. Provide support for domestic (federal, state, and local) and International products registrations, by: Researching existing documentation, preparing summary information, memos or statements (including CFG’s; certifications, apostille, and consularization). Partnering with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support. Assess global impact of changes to launched products and support notifications/submissions as required Supporting product life cycle management activities. Provide import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate. Review labeling and marketing literatures for compliance with regulatory requirements Participates in the annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals. Maintain knowledge and application skills of regulations, standards and codes within job scope by doing the following: Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products Monitor and evaluate medical device regulation changes and develop and execute strategies for maintaining products on the global market. Performs other duties as needed and assigned. Your Qualifications Education: BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience. Related Experience: Minimum of 3-6 years of Regulatory experience in medical device industry is required. Minimum of 2 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities. Special Competencies or Certifications: Regulatory Affairs Certification (RAC) a plus Knowledge of U.S. and International regulatory requirements for medical devices Proven record of supporting project teams Good Microsoft application skills Excellent written and oral communication skills Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820 Work Environment / Conditions: Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc. Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc. Ability to travel nationally /internationally, up to 5-10% of the time The targeted pay range for this position is typically between $84,100 - $100,900 . We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job-related knowledge, skills, experience, and other objective business considerations.​ This position is eligible for the following additional compensation:annual bonus. Dräger Benefits At Draeger, Technology for Life means supporting our people in every aspect of their lives. We offer a competitive benefits package that may include: Medical, dental, and vision insurance Life, short- and long-term disability coverage 401(k) with company match Over 4 weeks of paid time off, plus holidays and parental leave Flexible spending accounts and employee assistance program Select locations also offer free parking, an on-site gym, cafeteria, and game room. Talk to your Draeger recruiter to learn more! Who we are We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle “Technology for Life”. Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario. Draeger is an Equal Opportunity Employer. Interested? Please, apply directly through our career portal. We look forward to receiving your application.