EU Regulatory Affairs Manager

The Kerr Dental portfolio of brands and product solutions spans restoratives, endodontics, and rotary instruments, with a common purpose of enabling healthy, beautiful smiles while providing an exceptional customer experience globally. Kerr’s 130 year history of innovation began in 1891 in Detroit, Michigan and has since expanded on a global scale to ensure dental professionals receive the consumable products they trust most.  Kerr’s market-leading brands include OptiBond, SonicFill, Harmonize, MaxCem Elite, and many more. Learn more at www.kerrdental.com

Job Description:

Summary:

The EU Regulatory Affairs Manager is responsible for European region, with focus on the (EU) Medical Device Regulation (MDR). This individual will be responsible for product approval submission activities, MDR implementation and certification for new and legacy products, and special projects. Furthermore, this individual is responsible for, as applicable, managing a Regulatory Affairs team, implementing policies, procedures, best practices, and collaborate with cross-functional teams within the business units to develop and execute regulatory strategies from product inception to product launch.

Essential Duties and Responsibilities: 

• Prepare and/or oversee Technical File, CE Mark, and other related regulatory filings. 
• Ensure the timely and accurate submission(s) of regulatory documentation, along with timely and precise responses to deficiencies.
• Interprets applicable standards, regulations, and directives to ensure Regulatory compliance. 
• Advising on MDR for new product development.
• Collaborate with Clinical Affairs to develop clinical plans per EU MDR.
• Prepare and/or oversee regulatory assessments.
• Review regulatory content for claims support of promotional material, labeling content, product and process changes, and product documentation.
• Interact with regulatory agencies as part of submission review and on-site audit support.
• Participate in compliance activities, such as applicable audits (Notified Body, Government Authority, Corporate, Internal, etc.).
• Keep abreast of regulatory procedures and changes.
• Support implementation of new policies by serving as RA subject matter expert.
• Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management.
• Develop, review and support maintenance of regulatory SOPs.
• As appropriate, provide direction, manage activities, and participate in development plans with Regulatory Affairs Staff.
• As appropriate, manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction.
• Lead by providing the motivation and inspiration to work effectively toward organizational goals and the individual objectives for reaching the goal.
• Foster and maintain strong relationships with senior RAQA Regulatory leaders across the company and leverage best practices and opportunities to drive cross business collaborations and initiatives.
• Perform special projects as needed.

Scope:

Europe and applicable international countries

Supervisory Responsibilities:

This job has supervisory responsibilities.  Able to lead teams and perform as a team member, superior communications, and excellent interpersonal relationship abilities.

Job Requirements:

Qualifications:

• Bachelor's Degree (BA/BS) from four-year college/university required.
• 4 years related experience and/or training in an FDA-regulated industry.
• A minimum of 7 years of related experience is required with a bachelor’s degree, OR, a minimum of 5 years of related experience is required with a Master’s degree.

Preferred Qualifications:

• 3 years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
• Engineering or Advanced degree desired
• Proven track record of leading high performing teams
• Excellent oral and written communication skills, including the ability to discuss regulatory strategy and requirements with senior management
• Exceptional attention to detail
• Multi-tasks and prioritizes effectively in fast-paced environment
• Enthusiastic team player with an ability to collaborate with diverse teams
• Excellent organizational and multi-project management skills
• Strong ability to problem solve and apply analytical thinking
• Ability to manage conflict resolution
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism

Language Skills:

Well-developed technical writing skills including presenting technical information in the context of regulatory requirements.  Strong listening skills.  Communications with regulatory bodies on significant matters, including formal response to regulators on submissions, with minimal to no supervision.  

Mathematical Skills:

Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.   

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills:                  

Strong computer skills in Word, Excel and Powerpoint

Certificates, Licenses, Registrations:

RAC certification desired.

Other Skills and Abilities:

Ability to effectively translate regulatory requirements into practical advice to cross-functional teams and other audiences.  Crisp decision-making capabilities, delegation, managing to tight deadlines, prioritization of work for self and subordinates. 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

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Operating Company:

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.