Sr. Manager, Regulatory Affairs

Shockwave Medical Santa Clara , CA 95050

Posted 1 week ago

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Senior Manager, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Manager, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with responsible Regulatory Affairs management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Senior Manager, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Essential Job Functions

  • Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units
  • Manage, mentor, and develop direct reports to meet individual and company goals and objectives
  • Develop, follow, and train key personnel on regulatory policies, processes and SOPs
  • Develop and implement regulatory strategies and update strategy based upon regulatory changes
  • Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order to effectively meet the requirements
  • Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development and operations teams
  • Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
  • Effectively and accurately write and edit technical documents
  • Review and approve R&D, quality, preclinical and clinical documentation for submission filing
  • Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
  • Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
  • In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
  • Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
  • Effectively communicate application progress to internal stakeholders
  • Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
  • Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies
  • Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation
  • Provide regulatory input for product recalls and recall communications
  • In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives
  • Review and approve advertising and promotional materials to ensure regulatory compliance
  • Evaluate, provide guidance and implement import/export requirements
  • Identify emerging issues and regularly communicate status
  • Provide other country specific regulatory support
  • Plan and conduct meetings, create project plans and timelines, and manage projects
  • Exercise good and ethical judgment within policies and regulations
  • Perform multiple tasks concurrently with accuracy
  • Other duties as assigned

Requirements

  • Bachelor's degree in science, math, engineering, or medical fields is preferred. Post-graduate degree in a technical area, M.B.A. or law is preferred
  • Minimum 12 years experience in a regulated healthcare industry. Class III medical device experience preferred
  • Minimum 2 years prior management and positive mentorship experience is preferred
  • Medical device software engineering background or experience is preferred.
  • Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
  • Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions, such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, etc.
  • Ability to outline sound regulatory strategy in alignment with regulations and business priorities
  • Think analytically with excellent problem-solving skills
  • Effectively negotiate internally and externally with regulatory agencies
  • Clear and effective verbal and written communication skills with diverse audiences and personnel
  • Knowledge of business functions and cross group dependencies/ relationships.
  • Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met
  • Leadership of functional groups in the development of relevant data to complete a regulatory submission
  • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
  • Able to effectively and positively lead direct reports while demonstrating flexibility to changing environments
  • Proficient in MS Word, Excel, Adobe and Power Point

Benefits

Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Medical Device Regulatory Affairs Development (Rad) Program

Abbott Laboratories

Posted 2 weeks ago

VIEW JOBS 10/15/2020 12:00:00 AM 2021-01-13T00:00 Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. We currently have multiple opportunities for the Medical Device Regulatory Affairs Development (RAD) Program. This position is included in the Medical Device Regulatory Affairs Development (RAD) Program and performs multiple rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory business such as the regulatory database and global regulatory SharePoint sites. WHAT YOU'LL DO * Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives. * Creates, reviews and approves engineering changes. * Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines. * Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. * Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested. * Supports the product release process by creating GTS licenses or reviewing and approving requests for product release. * May interface directly with FDA and other regulatory agencies if so directed. * Reviews protocols and reports to support regulatory submissions. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. * Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. * Performs other related duties and responsibilities, on occasion, as assigned. EDUCATION AND EXPERIENCE YOU'LL BRING Required * Ability to work in a highly matrixed and geographically diverse business environment. * Ability to work within a team and as an individual contributor in a fast-paced, changing environment. * Ability to leverage and/or engage others to accomplish projects. * Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. * Multitasks, prioritizes and meets deadlines in timely manner. * Strong organizational and follow-up skills, as well as attention to detail. * Ability to maintain regular and predictable attendance. * Ability to move to various US locations based on rotational assignment Preferred * BA or BS degree in life sciences (i.e., chemistry, biology, etc.) or engineering (i.e., biomedical, mechanical, chemical, etc.). * Some experience with medical device industry preferred. * Experience working in a broader enterprise/cross-division business unit model preferred. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: * Training and career development, with onboarding programs for new employees and tuition assistance * Financial security through competitive compensation, incentives and retirement plans * Health care and well-being programs including medical, dental, vision, wellness and occupational health programs * Paid time off * 401(k) retirement savings with a generous company match * The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. Abbott Laboratories Santa Clara CA

Sr. Manager, Regulatory Affairs

Shockwave Medical