Principal Regulatory Affairs Specialist

Job Summary

Responsibilities

The Principal Regulatory Affairs Specialist will be part of this high-performance team and responsible for developing regulatory strategies, preparing U.

S. and major market submissions and obtaining approval to introduce new spinal implants and biologics worldwide.

These responsibilities are performed through the collaboration with various functions across the Operating Unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality and Marketing.

Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements.

The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new solutions based on experience and working collaboratively within the Regulatory department other business functions.

• Support New Product Development on project teams on behalf of RA, developing and implementing Regulatory strategies and deliverables for US, EU and International (OUS).
• Participate on the Product Development team and responsible for identifying submission deliverables, timelines, and strategic direction.

Reviews and approves technical documentation.

• Prepare regulatory submissions such as US pre-submissions, 510(k)s, IDE, and Letter-to-File submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
• Provide product change assessments and define regulatory impact of product changes for Class II, Class I and biologics (bone graft)products.
• Attend internal and external audits / inspections in a Regulatory capacity and address any issues or concerns, and support the Quality System Management Representative, as appropriate.

Provide guidance to the team on change assessments and reportability.

• Negotiate with regulatory authorities to resolve questions / issues that arise prior to and during product submissions.
• Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
• Interact directly with FDA and other major market regulatory agencies in support of product registration, approval, and commercialization.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide business and product information to international regulatory staffs to enable development of strategies and requirements for global commercialization.
• Provide feedback and on-going support to product development teams to assure timely resolution to regulatory issues and questions.
• Other duties as assigned.

Role Requirements

• Bachelors degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience or minimum 5 years of medical device regulatory affairs experience with Master’s degree

Skills and Knowledge

• Advanced degree in a scientific discipline (engineering, physical / biological or health sciences)
• Regulatory experience within the medical device industry preparing Pre-submissions, 510(k)s submissions and STEDs is required.

Biologics (bone grafts) and orthopedic devices regulatory experience is highly preferred.

• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical skills
• Extensive experience at formulating successful regulatory strategies that meet established approval timelines, while maintaining the highest level of quality
• Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, US and major market regulatory requirements, project management, and negotiations
• Experience interacting with regulatory agencies
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Demonstrated ability to work well in dynamic and cross functional team environments
• Demonstrated collaboration and leadership skills in team setting
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Experience reviewing design specifications and other technical documents
• Excellent interpersonal and communication skills, both oral and written
• Working understanding of computer applications; proficient in Microsoft Office Applications
• Minimal overnight travel required

Target Pay Range

$150,801 - $207,351. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography.

Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city / state.

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and / or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.