HireDiversity

Ciudad de México, MX

Regulatory Affairs Manager (Medical Devices)-000009GH

Description

"The Johnson & Johnson Family of Companies provides equal job Opportunities to all candidates"

Company description:

Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care.

Searching the best talent for: Regulatory Affairs Manager

General description:

Manages activities concerned with the submission and approval of various medical device or other categories of products to government regulatory agencies.

Represents J&J at local Associations, MoH and external organizations.

Functions:
- Supervises the work of RA Sr. Specialists, Specialists and Associates.
- Responsible for performance evaluations and development plans
- Establish and prepare appropriate regulatory filings for product approvals.
- Responsible for planning and organizing the team's regulatory activities, including resource allocation and prioritization of all processes.
- Dashboard and performance indicators management.
- Maintains current and in-depth knowledge of Country, sub-region and Worldwide Regulatory authority programs, policies and other critically important regulatory information that may affect the company's products and customers.
- Leads the development and execution of an effective regulatory affairs strategy to ensure best possible relations with various regulatory agencies.
- Plans and supervises regulatory activities for assigned programs and establishes priorities for submissions based on departmental goals and objectives and establishes schedules and assigns work to staff
- Ensures there is a process in place for regulatory database update and accuracy
- Oversees the regulatory activities with OC & regional team to ensure timelines for product registration and key projects are met
- Ensures timely and accurate communication with customers, anticipates franchise needs and incorporates them in the RA submission plan.
- Act as the link between functional areas and franchises with the rest of the RA team in the country-region
- Develops a collaborative environment with other company´s and commercial areas
- Responsible for people´s management processes and results within the reporting working team
- Manages outsourced capabilities/temps & contractors to manage peak demand
- Prepares submission status reports for review at meetings and by management
- Supports the RA Sr Manager in the country/region in external environment activities to proactively shape the environment.
- Provide support to RA Regional Managers & assist with various projects as assigned (one, or may cross several, franchise groups)
- Communicate with department members, other JJ personnel, government agencies in a professional, decisive, & articulate manner
- Liaison with local regulator and OC to answer questions regarding product submissions
- Maintain an appropriate level of professional competence through participation in industry association & continuing education programs
- Make recommendations & provide guidance to marketing, package engineering & regulatory personnel regarding label content (mainly for Drugs and Biologics)
- Manage the regulatory aspects of new product registration for designated products with minimal direction from management
- Participate with management in communications with local regulators, trade associations, and OCs
- Prepare and lead training for junior regulatory affairs personnel
- Assists in the preparation and control of department budget
- Conduct reviews with local marketing and status updates with other local partners.
- Identify the need, communicate to Quality and prioritize GMP inspections as needed.
- Technical Responsible person in countries where required

Reports to: SR Regulatory Affairs Manager

Cualificaciones

Qualifications:
- Must have 5 years experience working in a Regulatory Environment preparing submissions for complex devices or other product categories and a successful track record.
- Must have 1-2 years direct management experience.
- Experience in working on industry working groups or cross J&J experience.
- Multi country experience desirable.
- A Bachelor's Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Advanced Degree preferred. Bi-lingual: English - Spanish or Portuguese
- Advanced computer skills

Competencies:
- Solid Knowledge of International regulatory processes
- Excellent analytical capability, communication skills essential.
- Demonstrated ability to manage, motivate, and develop a staff of regulatory professionals.
- Critical thinking
- Must be able to work in a timeline-driven environment
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
- Problem Solving - sorting through ambiguity to design solution plans; creative and compliant solutions to day to day issues
- Ability to apply system knowledge to offer practical solutions to minimize compliance risk, while balancing business needs
- Conflict Management
- Diplomatic interfacing with all levels of management.
- Networking - establish & maintain appropriate contacts in regulatory community

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Leadership Imperatives:

· Integrity & Credo-based Actions

· Create a trusting, collaborative, and ethical work environment

· Maintain the highest standards of quality, compliance and accountability

· Cultivate external relationships and partnerships

· Forge internal collaboration across all levels ofthe enterprise

· Challenge the status-quo; lead and adapt to change

· Take and manage risks

· Empower people to act with speed, agility and accountability

· Demonstrate a global and enterprise-wide mindset

· Take ownership for talent acquisition, performance and development of self and others

· Maximize the power of diversity and inclusion

Ubicación principal: America Latina-México-Distrito Federal-Ciudad de México

Organización: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)

Área: Regulatory Affairs