Director of Regulatory Affairs

Job Responsibility:

Avania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that fosters growth, innovation, and collaboration.

Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.

Avania is hiring - Director of Regulatory Affairs

The main responsibility of the Director of Regulatory Affairs is to provide leadership and technical oversight of regulatory and clinical study design projects within the Regulatory and Advisory Services department, as well as manage consultants performing project work, additionally the Director of Regulatory Affairs will support business development activities, including research into the product and regulatory landscape for novel medical devices, and designing service offerings to meet individual client needs, with consideration for the client's unique device and target therapeutic area, commercialization strategy and key milestones, and internal team resourcing. The successful candidate will have significant hands-on experience developing and executing regulatory strategy for novel med-tech products, including interaction and negotiation with the US FDA and other global regulators.

In addition to the above, the Director, Regulatory affairs role will also include the following:

General Responsibilities:

• Proactively communicate project status to the Vice President of Regulatory and Advisory Services, other related departments, and clients.
• Identify current industry trends and bring forward implementation solutions to the team.
• Proactively provide client services when need or requested, ensuring that deliverables are met in a timely manner.

Business Development:

• Maintain a portfolio of clients.
Independently design service offerings to meet client needs (both expressed and implied from conversations).

People Management:

• Conduct and finalize annual performance appraisals for direct reports, which may include Consultant I, Consultant II, Senior Consultant, Principal Consultant, and Manager, providing feedback, goal-setting, and professional development guidance.
• Assess team members' growth and contributions to identify promotion opportunities, ensuring career progression aligns with performance and organizational needs.
• Recognize and address performance challenges proactively through direct, timely interventions, collaborating with Human Resources as needed to develop and implement Performance Improvement Plans (PIPs).
• Evaluate staffing needs and contribute to the hiring process by defining resource requirements and supporting recruitment efforts to build a strong, capable team.

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply. With our continued growth we are hiring talent to join us on our journey and grow with us.

We seek -

• Minimum of 8 years of work experience with a MedTech company and/or as a consultant in the MedTech industry, to include Direct management of teams and projects
• Advanced (Masters, PhD, MD or equivalent) degree in health care, science, technology or industry-related discipline.
• Broad knowledge of medical device best practices, law and regulations, inside and outside US, from initial concept through commercialization.
• Experience with regulatory submission preparation such as IDE, 510(k), PMA, De Novo, HUD, EU Technical files.
• Experience negotiating and interacting with global regulators, including FDA Center for Devices and Radiological Health (CDRH).
• Experience with design and conduct of clinical trials within and outside the US.
• Proficient in the use of computer and software systems (Microsoft Word, Excel, PowerPoint, email).
• Fluent in English, spoken and written.
• Ability to travel domestically and internationally

Competencies

• Demonstrated leadership managing medical device projects and teams.
• Ability to interact with Senior level client personnel, Board of Directors, and Investors.
• Ability to independently analyze and provide project forecasts.
• Demonstrated record of business lead generation and ability to sell services to new clients.
• Able to cope with high pressure and challenging environment.
• Flexible, but focused and persistent.
• Excellent interpersonal and communication skills (oral and written).
• Strong organizational and time management skills; capable of delivering high quality results in a timely manner.
• A team player with leadership skills.
• Client focused.
• Proactive.
• Strong client management capability.
• Detail-oriented, but equally able to communicate the bigger picture to cross-functional stakeholders

We offer -

• The opportunity to work in an innovative, fast-growing and rewarding industry
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Competitive compensation and benefits package (details shared during the interview process)
• Some roles offer the opportunities for travel
• Ask us about our hybrid and fully remote work opportunities

We look forward to receiving your application!

Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

#LI-DNI