Regulatory Affairs Lead Benelux, JNJ MedTech

Job title:

Regulatory Affairs Lead Benelux, JNJ MedTech

Company:

Johnson & Johnson

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more atJohnson & Johnson MedTech is recruiting for a Benelux Regulatory Affairs Lead MedTech located in Netherlands or Belgium.The role is responsible for ensuring compliance with Medical Device regulations, related legislation, standards, etc. This role requires deep domain expertise in local and EU regulatory requirements for Medical Devices and Drugs. Key responsibilities include managing projects and activities related to the assessment and maintenance of regulatory systems, effectively communicating with key stakeholders, and analyzing regulatory guidelines:

• Ensures Regulatory Compliance of Medical Devices (MD) facilitating local markets access (Belgium, Netherlands and Luxembourg) for the full product life cycle – Compliance with both local country requirements and the EU MDR.

• Provides strategic guidance to the commercial organization related to regulatory requirements and develops recommendations pertinent to the local or bigger business in accordance with local and EU regulations and relevant guidelines.

• Provides advice, counsel, and expertise on RA issues, both proactively and reactively.

• Represents the local market and its requirement in various internal forums and stakeholders, including the commercial, regional and global base business organizations.

• Represents J&J in various internal and external forums such as Trade Associations, meetings with local Health Authorities, etc.

Key Responsibilities:

• Demonstrates deep domain expertise in the regulatory requirements for local and EU registrations, licensing and other RA compliance related matters.
• Partners closely with internal stakeholders across Johnson & Johnson (e.g. local commercial organization, central and regional strategy teams) to ensure that the compliance-related requirements are evaluated and executed within the local commercial launch plan strategies. The same applies for product modifications.
• Analyzes, interprets, and synthesizes regulations and guidelines, and provides clear and timely communication of new and changing requirements to the base business regulatory teams and updates to the local procedures accordingly.
• Educates internal stakeholders on local regulatory requirements and integrating those requirements into procedures.
• Ensures adherence to standard operating procedures and protocols and adjusts processes to improve efficiency or align with compliance requirements.
• Efficiently executes local Pre-marketing Regulatory activities including documentation check, license updates, system updates to ensure product restriction releases (including MDRIM, RAD, Cignon).
• Drives lifecycle initiatives from Regulatory, partnering with the local commercial organization.
• Oversight and management of company license or registration for MDs, Medicine, Veterinary products, and Human Tissue products, including importer and distribution responsibilities as required.
• Provide regulatory support (in collaboration with business and regional Regulatory Affairs) to marketing, sales representatives, Customer Service, especially for tenders.
• Supports announced and unannounced inspections by Competent Authorities.
• Liaison with local Competent Authorities.
• Supports Johnson & Johnson Internal Regulatory Compliance Audits.
• Ensure all post marketing regulatory requirements are met, with an emphasis on ensuring all external communication/marketing materials are compliant with local and regional guidelines and restrictions (Copy review for medical devices and medicine.
• Review and approval of translated labelling of medical devices and medicine in local languages.
• Identifies and facilitates continuous improvement activities (self, team, procedures, systems, etc.).
• 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.
• Responsible for ensuring personal and Company compliance with all local and Company regulations, policies, and procedures.
• Rapidly identifies and reports regulatory concerns to Management and Franchise, investigate and suggest solutions to resolve them.
• Ensures the execution of POLO Economic Operator Verifications (EOV).
• Performs other duties assigned as needed.

QualificationsEducation:· Minimum requirement: Bachelor’s degree.· Advanced degrees and education in pharmacy, medicine, engineering, or science.· A minimum of 5-8 years of medical device and/or medicines regulatory affairs experience required in an International Company.· Languages: English (Advanced), Dutch, notion in French language will be advantageous.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.Experience and Skills:Required:

• Excellent Communication and presentation skills;
• Proactive and strategically orientated;
• Demonstrates deep domain expertise in the regulatory requirements for local and EU regulatory requirements for Medical Devices and Drugs;
• Ability to persuasive communicate and influence key stakeholders;
• Skilled in establishing partnerships and collaboration with commercial partners, business RA and regional RA, as well as other stakeholders;
• Strong results-orientation and sense of urgency;
• Solid capacity to analyze, interpret and synthesize on regulation and guidelines;
• Strong capability of self-awareness and adaptability;
• Understanding of the linkages in Vigilance and Regulatory Compliance;
• Ability to effectively present information to management and public groups;
• Change management experience and strong influencing skills;
• Ability to comprehend the Regulatory environment and understand its impact on the Business;
• Ability to interact with trade associations and authorities for advocacy activities.

Expected salary

Location

Amersfoort, Utrecht

Job date

Thu, 27 Jun 2024 02:02:12 GMT

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