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Regulatory Affairs Expert
1 month ago
Company Overview
Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains.
Salary
The estimated annual salary for this position ranges from $102,000 to $128,000, depending on skills, experience, and location.
Job Description
Position Overview
The Principal Regulatory Affairs Specialist plays a key role in ensuring that products meet regulatory requirements. This individual contributor works closely with internal departments to efficiently meet assigned regulatory deadlines, particularly for the Reducer product business at Shockwave Medical Inc.
This specialist combines knowledge of scientific, regulatory, and business issues to guarantee that products are developed, manufactured, and distributed according to regulatory standards. Under the direction of responsible Regulatory Affairs Management, they work independently with minimal oversight, making decisions on regulatory matters, ensuring timely registration and renewal, and supporting new product development as assigned.
Key Responsibilities
- Collaborate with various levels on significant matters, often requiring coordination across organizational units.
- Develop regulatory policies, processes, and SOPs, and may train key personnel on them.
- 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 RD, 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.
Requirements
- A minimum of 10 years of related experience with a Bachelors degree; or 8 years and a Masters degree. A degree in science, math, engineering, medical, or other technical fields and Class III medical device experience are preferred.
- 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.
- Some medical device software engineering background or experience is preferred.
- Proficiency in MS Word, Excel, and Power Point required.
Benefits
Shockwave Medical offers a competitive total compensation package, including core benefits like medical, dental, vision, pre-tax and Roth 401k options with a fully vested match, short-term and long-term disability, and life insurance, employer contribution toward Health Savings Account (HSA), and competitive PTO balance. Additional perks include Calm App, Pet Insurance, Student Loan Refinancing, and Spot Bonus awards.
