VP Regulatory

Exactech, Inc.
Job Description

Job Details

Description

 Purpose:

To lead the Regulatory Affairs team and ensure Exactech’s compliance to the code of ethics and Quality Management Systems.

Duties and Responsibilities (Key Deliverables):

1. Providing oversight for Exactech’s global regulatory operations including the obtaining and maintenance of facility and product licenses/registrations (e.g., FDA PMA and 510(k), EU CE Mark, and Canada MDL).

2. Collaborate with Business Units and International Marketing to develop and communicate the cadence of approvals for new product development and sustaining engineer projects.

3. Design regulatory strategies to support business decisions, product applications and claims, from development through product lifecycle management. Keep peers and superiors apprised of expected changes to the regulatory landscape affecting the performance of existing and new products.

4. Develop and maintain strong relationships with the Regulatory Agencies.

5. Coordinate and collaborate with business units, product development, clinical, quality leaders across the organization.

6. Performing the necessary resource management, budgeting and workload prioritization activities to facilitate the teams’ meeting of company goals and objectives.

7. Oversee development and refinement of regulatory policies and procedures and SOPs.

8. Serve as point of contact and represent the company before regulatory authorities, including preparation of meeting agendas, materials, and minutes.

9. Manage and oversee of all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory FDA, EMA and PDMA applications, safety, amendments, and IND safety and annual report.

10. Practice leadership as stated in the Exactech Leadership Model 

     a) Ensure organizational alignment in the design and execution of initiative efforts

     b) Establishes clearly defined individual goals

     c) Responsible for hiring and terminations within the department as required

     d) Provide leadership to include effective feedback on culture, results and future, coaching and mentoring, performance                   management and career development

e) Assure compliance to the code of ethics

11. Establishes clearly defined department goals. 

12. Identifies the training needs of the department and ensures that the appropriate training is obtained in a timely manner. 

13. Know and apply the Quality System and any appropriate Federal and International standards.

14. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:
Education: Bachelor’s Degree from an accredited institution required; Master’s Degree preferred

Experience:

• Minimum 15 years’ experience in US and International medical device regulations required.  

• Mastery of EU MDR requirements, FDA submissions, and all other international licensing and submissions requirements.  

• Orthopedic device experience preferred.

• Minimum 10 years’ experience in departmental or organizational administration and management required.

• Expert at project management, planning and communication of critical RA deliverables.  

Functional/Technical Knowledge, Skills and Abilities Required:

• Strong leadership skills including assuring the effectiveness of functional and cross-functional teams

• Demonstrated success in leading continuous improvement and organizational change

• Demonstrated problem-solving and analytical abilities

• Strong verbal communication and technical writing skills

• Competency with windows based office productivity tool

Qualifications

Education

Required

Bachelors or better.

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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