• Manage domestic and global product submissions, including 510ks, EU technical files, international registration dossiers, and state licensing.

• Act as Person Responsible for Regulatory Compliance (PRRC) per the requirements of EU MDR 2017/745, Article 15, including responsibility for the following, as applicable:

• Conformity of the device to the manufacturer's QMS prior to release

• Technical documentation and EU Declaration of Conformity (DOC) are up to date

• Post-market surveillance obligations follow Article 10(10)

• Reporting obligations referred to in Articles 87 to 91 are fulfilled

• The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices

• Complete regulatory assessments for new products or product modifications and develop regulatory strategies for their respective product launches domestically and internationally.

• Support and provide regulatory guidance on pre-production and design releases of new product development for domestic and international distribution.

• Manage regulatory compliance activities such as Health Hazard Evaluations, adverse event reporting and recall execution and reporting.

• Monitor and communicate changes to domestic and international regulations, legislation, guidance documents and policy to determine impact to the organization.

• Conduct research on applicable standards and guidance documents to provide Design Verification and Validation testing requirements and recommendations for new or revised medical devices.

• Collaborate with Engineering, Operations, and Quality Assurance to create, edit, submit, defend, and maintain technical documentation required for medical products.

• Assist in documenting and executing post-market nonconforming product processes, such as reportables/adverse events, field safety notices, and recalls/corrections/removals.

• Provide assistance during government inspection activities including inspectional observations as well as corrective action plans.

• Interface with regulatory agencies (FDA, DEA, State BOP, DOT, OSHA, EPA, etc.) and review/approve changes to company policies and procedures.

• Manage and participate in a variety of quality and regulatory projects as required.

• Manage, coach, and direct daily activities and priorities of the Regulatory Affairs team. Provide guidance and development opportunities as needed.

• Select, develop, and evaluate employees to ensure the efficient operation of the department.

• Experience within the medical device and/or pharmaceutical industries.

GENERAL SKILLS & COMPETENCIES:

• Strong management and leadership skills and ability to attract, retain, motivate, develop and mentor team members for high performance

• Outstanding verbal and written communication skills and ability to resolve disputes effectively

• Excellent presentation and public speaking skills

• Excellent independent decision making, analysis and problem solving skills

• Understand and act on financial information that contributes to business profitability

• Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility

• Lead team(s) to achieve company goals in creative and effective ways

• Excellent planning and organizational skills and techniques

• Communicate effectively with senior management

• Good negotiating skills and ability to effectively manage outsourced relationships

• Ability to influence, build relationships, understand organizational complexities and manage conflict

• Broad professional and managerial skills with a good understanding of industry practices and company policies and procedures

• Ability to lead virtual teams

MINIMUM WORK EXPERIENCE:

Typically 10 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 1 or more years of management experience.

PREFERRED EDUCATION:

Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus.

TRAVEL / PHYSICAL DEMANDS:

• Periodic travel may be necessary, including visiting the manufacturing facility at least once per quarter. Travel approximately 15-20%.

• Remote office environment. No special physical demands required.

The posted range for this position is $95,040-$166,320, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.

This position is eligible for a bonus/incentive not reflected in the posted range.