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Senior Manager Regulatory Affairs
2 months ago
Position: Senior Manager, Regulatory Affairs
Location: Morrisville, NC (Onsite 3 days a week, Tuesday-Thursday)
Salary: Base salary of $160K-$170K with a potential 16% bonus and eligibility for long-term incentives (RSUs)
Relocation: Candidates willing to relocate will be considered
Overview:
We are seeking an experienced Senior Manager of Regulatory Affairs to join our Global Operations team. This leadership role requires a strong understanding of global regulatory requirements and a proven ability to navigate complex regulatory landscapes. The Senior Manager will lead regulatory strategies, submissions, and compliance initiatives, directly contributing to the company’s growth in the medical device industry.
Key Responsibilities:
- Develop and execute regulatory strategies for new product development, including classification, pathway selection (510(k), PMA, De Novo, etc.), and global market access.
- Lead a global team of four, providing performance management, talent development, and succession planning.
- Collaborate with R&D, Clinical, Quality, Legal, and Marketing teams to align regulatory strategies and ensure compliance throughout the product lifecycle.
- Oversee the preparation and submission of regulatory documents, ensuring adherence to relevant regulations and guidelines.
- Maintain relationships with regulatory authorities worldwide, facilitating submission approvals and addressing queries.
- Assess and manage risks associated with products and regulatory changes, implementing risk mitigation strategies as needed.
- Support regulatory audits and inspections, coordinating responses and addressing findings.
- Monitor evolving global regulations and communicate impacts to internal stakeholders.
- Provide regulatory due diligence for mergers, acquisitions, and partnerships to ensure compliance.
- Maintain organized and accessible regulatory files and documentation.
- Uphold their Code of Ethics and adhere to company policies and procedures.
Qualifications:
- Bachelor’s degree in science, engineering, or a related field; equivalent experience may be acceptable in lieu of a degree.
- 7-10 years of experience in Medical Device Regulatory Affairs, with a focus on Class I and II devices; Class III experience preferred.
- 5-7 years of leadership experience with a proven ability to motivate and manage teams.
- RAC certification is a plus.
Skills and Attributes:
- Strong leadership and collaboration skills, with the ability to influence others without direct authority.
- Excellent analytical and critical thinking abilities, enabling the development of innovative solutions.
- Strong verbal, written, and presentation skills.
- Proficient in MS Word, Excel, PowerPoint, and Outlook.
- Willingness to travel domestically and internationally.
