This position is onsite in San Diego.

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role

The Director, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively manage assigned regulatory requirements for Mainstay Medical. The Director, 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 Regulatory Affairs management, functions independently as a decision-maker on regulatory issues, assures on both a strategic and tactical level that submission/registration/renewal deadlines are met, and supports new product development, when assigned. Effectively communicates and negotiates both internally and externally with various regulatory agencies. Properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Position Responsibilities:

• Strategic planning and tracking of registration activities (including labeling) with accountability for successful completion within agreed timelines to deliver new, modified and/or renewal licenses and to ensure regulatory compliance and market access and provide regulatory support for global product registration projects.
• Accountability for creation and maintenance of Product Dossiers to support global filing activities.
• Advise regulatory affairs teams on creation of local regulatory affairs strategy, change implementation, and potential high impact risks.
• Build and maintain trusted relationships with cross-functional business partners, local regulatory agencies, and national/regional trade associations.
• 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.
• Collaboration with internal/external stakeholders on global regulatory activities, change impact, and product recalls; act as a point of contact for regulatory authorities.
• Review of supplement labeling to comply with local regulatory requirements.
• Analyze local regulatory trends and market intelligence information.
• Effectively and accurately write and edit technical documents. 
• Manage a team and develop a robust talent development plan in alignment with functional growth strategies of the department.
• Identify and evaluate more complex process improvements in regulatory affairs (especially regarding registration and labelling) and/or course correction/alignment opportunities.
• Educate employees on regulatory affairs impact (e.g., registration of new products). Define and communicate guidelines for business partners.
• Other incidental duties.

Qualifications:

• Bachelor's Degree or Master's Degree or Equivalent in a related field (Medical Device) previous related experience 

• 10 years of experience with at least 5 years of functional and/or people management experience
• Ability to travel up to 20%

• 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 in various worldwide geographies
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities
• Ability to 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
• Follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues
• Effectively and positively lead direct reports while demonstrating flexibility to changing environments
• Proficient in MS Word, Excel, Adobe, and PowerPoint

The salary range for this position is $199,000 to 214,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.