Be an early applicantLess than 25 applicants

Company

Shockwave Medical · 1 day ago

Principal Regulatory Affairs Specialist

Austin, TX

Full-time

Remote

Lead/Staff

$102K/yr - $128K/yr

10+ years exp

Maximize your interview chances

BiotechnologyHealth Care

Insider Connection @Shockwave Medical

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units

Develop regulatory policies, processes and SOPs and may train key personnel on them

Develop regulatory strategies and update strategy based upon regulatory changes

Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders

Provide input and technical guidance on regulatory requirements to 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)

Review and approve R&D, quality, preclinical and clinical documentation for submission filing

In collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities and coordinate/communicate with distributors and other agencies for filing purposes mainly focused outside the US, as assigned

Interact and negotiate with distributors, authorized reps, in-country staff, and directly with regulatory authorities during the submission and review process to ensure submission approvals

Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements

Oversee 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

Review and approve advertising and promotional materials to ensure regulatory compliance

Evaluate import/export requirements

Identify emerging issues

Provide other country specific regulatory support

Effectively and accurately write and edit technical documents

Plan and conduct meetings, create project plans and timelines, and manage projects

Exercise good and ethical judgment within policy and regulations

Perform multiple tasks concurrently with accuracy

Provide guidance to functional groups in the development of relevant data to complete a regulatory submission

Other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsMedical Device ExperienceRegulatory SubmissionsISO StandardsTechnical WritingProject ManagementMedical Device Software EngineeringMS WordMS ExcelMS PowerPoint

Required

Typically requires a minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree.

Ability to work collaboratively in a fast-paced environment while managing multiple priorities.

Detailed working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.

Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and international filings (TGA, Health Canada, Shonin, CFDA, etc.)

Ability to outline sound regulatory strategy in alignment with regulations and business priorities.

Think analytically with good 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.

Leadership of functional groups in the development of relevant data to complete a regulatory submission.

Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Proficiency in MS Word, Excel and Power Point required.