Staff Regulatory Compliance Specialist - 2406185275W

Description

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in Medical Devices (i.e. implantable devices such as breast implants), 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 internal audits of the Compliance program. Serves on site 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 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 Internal commitments to mitigation of identified risks as part of the Internal audit program. Supports in the completion of Follow Up reports related to the tracking and completion of Internal function 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 audit compliance follow-up program.

• Owns relationship with internal 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.

• Ensure adherence to the internal audit schedule, ensure qualified personnel performs the audits and generate timely audit reports, and support auditees with investigations and action plans in response to the audit observations.

• Audit/Inspection Readiness: supports Company efforts in the preparation activities for external audits and regulatory inspections.

• 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.

• Communicates effectively (written and orally) with professional staff across departments and facilities.

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

• Performs according to the company's quality policy and corporate rules in all business activities with providers and customers within and outside the company.

• Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.

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

• Collects and coordinates data and prepares detailed reports for assigned compliance processes and within the framework of departmental procedures.

• Provide training to applicable functions on audit and inspection readiness. Conduct and/or support mock inspections. Assist in achieving the Company’s goal of being inspection ready at all times.

• Ability to lead, negotiate and influence others in a complex organization is required.

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

Duties and Responsibilities:

• Fully responsible to the maintenance and execution of the Internal Audit program

• Responsible for supporting all activities related to the support of External Audits

• 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

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

Qualifications

Experience, skills & proficiencies required:

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

• Required: 5-8 years of auditing experience in a medical device and/or pharmaceutical environment. Must be a current Lead Auditor Certified.

• Preferred: 6-8 years in medical device industry; 5 plus years of auditing experience in a medical device environment.

• 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

• Working knowledge of applicable requirements related to the MDSAP jurisdictions, and other applicable regulations and standards.

• 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 Lead 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.

What type of mark will YOU make?

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.

What’s in it for YOU?

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

• Ready to apply our knowledge and know-how

• Unique in our background and experiences

• The drivers of our own success

• 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.

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Mentor Medical Systems, B.V. (8808)

Job Function Quality Engineering

Req ID: 2406185275W