Vacature Staff Regulatory Compliance Specialist

Staff Regulatory Compliance Specialist

• Titel Staff Regulatory Compliance Specialist
• Functie Engineering
• Sub functie Quality (Eng)
• Locatie Leiden, South Holland, Netherlands
• Gepost nov 27 2023
• Referentie 23W

Beschrijving

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopaedic and interventional solutions, we seek to improve and enhance medical care for people worldwide. Together, we are working to craft the future of health through differentiated products and services.

This role will be responsible for supporting the external inspection and internal audits of the Source Compliance program. Serves on cross site and segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements.

General Summary / Key Responsibilities:

This role will be responsible for supporting the external inspection and internal audits of the site Quality systems and Compliance program. Serves on cross site and segment internal share audit program to achieve consistent company goals and objectives to improve overall compliance performance to established metrics and requirements.

Key elements of the role involve supporting the management, tracking to closure of External Manufacturers and Suppliers commitments to mitigation of identified risks. Supports in the completion of Follow Up reports related to the tracking and completion of External Manufacturing commitments taken to mitigate identified risks.

Under limited supervision, with general direction and in accordance with all applicable federal, state and local laws/regulations and corporate Johnson & Johnson, procedures and guidelines, this position:

· Supports development and implementation of source compliance follow-up program.

· Owns relationship with external partners to ensure timely mitigation of risks identified through audit program.

· Assures that quality records are updated in a timely manner and are in compliance with and company procedures.

· Assures compliance with regulatory requirements and internal Johnson and Johnson and Medical Device procedures by supporting quality inspections, report audits, internal and external facility evaluations, system audits, and data reviews that support company development projects.

General Summary:

· Ensures and maintains a state of inspection readiness for systems, processes, and procedures within area of responsibility.

· Assist in defining and providing compliance metrics to be used in management reviews, external inquiries, and periodic dashboards.

· Proactively engages with external partners to develop a robust supplier corrective action response.

· Identify process improvements related to standard operating procedures and systems to mitigate risk and drive a quality culture.

· Assists in the development, review, and implementation of procedures.

· Aligns with policies, procedures, and company and regulatory rules and norms.

· Maintains quality records where applicable per the records retention procedures.

· Ability to make the complex clear and easily understood by others.

· Demonstrated ability to work remotely and partner globally is required.

· This position may require up to 0-5% domestic & international travel.

· Responsible for communicating business related issues or opportunities to next management level

· For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

· Performs other duties assigned as needed

Kwalificaties

We are looking for someone to join the team who can demonstrate the capability and leadership qualities

· Required: 4-year college degree (Bachelor's Degree) or Equivalent in a technical or science-related field

· Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations), J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP and other applicable regulations and standards. Experience in Medical Device Industry.

· Medical Device experience is preferred however candidates with backgrounds in related industries are encouraged to apply.

· Proven experience and understanding of the regulations surrounding MD and EUMDR

· Experience, supporting and managing Health Authority & Notified Body Inspections, managing internal audit program, expertise in ISO 13485, EUMDR, FDA CFR 820 is a must.

· Preferred certifications on the following: Certified Lead Auditor, CMMI Assessor, Green Belt certified/Process excellence and project management.

· Verbal and written communication skills, project management, problem solving, business/financial acumen, presentation skills, training/education methodologies, people leadership, talent development, etc.

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world's healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything.

It's vital to us that you feel you can bring your whole self to work; at J&J we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive wage and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

What we're about:

We are passionate about our work and play vital roles across a range of professional subject areas, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we're each

· Committed to caring

· Responsible to our communities

· Passionate about doing what's right

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified individuals will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	staff regulatory compliance specialist
Startdatum:	02-12-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.