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Regulatory Affairs & Quality Manager
Spain and Portugal (Iberia)
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing close to 14,000 people around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
MISSION
To advance lives and the delivery of Healthcare by profitably developing, manufacturing and marketing value-driven products which meet the quality, integrity, service, and innovation expectations of our customers and patients while providing opportunities for our employees. As a result, we will optimize shareholder value and be a respected worldwide healthcare company.
PEOPLE DEAL
Advancing Lives and the Delivery of Health Care. ™
As an ambitious, entrepreneurial and growing business, Bard EMEA is the natural home for driven, ethical and accountable people that want to get noticed, make things happen and enjoy the rewards they truly deserve. Our people are independent and critical thinkers that thrive on the challenge of delivering sustainable growth and live by our values. At Bard EMEA, your commitment and hunger for results will enable you to achieve more, grow more and be more.
OUR PROMISES TO YOU
At Bard we want you to be entrepreneurial, enterprising & accountable – you’re trusted to run your own area and create your own solutions. We have a direct link between results and reward - great achievements merit great rewards. Expect a fast pace, change and growth - you’ll be busy, challenged and never bored! You can make a real impact and get noticed, we have a flat structure and accessible senior management.
SUMMARY OF POSITION WITH GENERAL RESPONSIBILITIES
A new and exciting opportunity has arisen for the position of Regulatory Affairs & Quality Manager in Iberia.
Reporting to the Vice-President Quality & Regulatory Affairs, EMEA, the successful candidate will be responsible for all the regulatory and quality strategies and priorities as agreed among Marketing, Regulatory, International Regulatory, International Quality, Division Regulatory, and country management. These should be combined with broad healthcare market awareness enabling a proactive view of opportunities and challenges for the Bard portfolio in terms of sales strategies and customer support.
This is a supporting role within the local organisation and a key player within the broader EMEA RAQA team. He/she will establish and reinforce a company culture defined by commitment to customers, quality, performance, results, collaboration and accountability.
The main objectives of the role will be the following:
• Manage all post-market regulatory and quality compliance activities for products placed on the market in Spain and Portugal, including
• complaints handling and Regulatory Authority reporting for medical devices in accordance with local and European regulatory requirements;
• product notifications to the national Regulatory Authorities in support of business plans and objectives;
• Quality Management System processes and procedures.
ROLE
The position will manage all the activities related to Regulatory and Quality for Spain and Portugal. In detail, he/she will be responsible to:
• Support local product launch and business activities to secure timely market access by making and maintaining the required product notifications; ensure products placed on the market are in accordance with national laws.
• Manage complaint handling and vigilance reporting activities in accordance with regional and local regulatory requirements, including review and submission of Vigilance Reports to the local Competent Authority.
• Execute Distribution Holds and Field Safety Corrective Actions in accordance with regional and Business Division processes and procedures.
• Implement Bard Corporate and European procedures and processes including Quality Management System reviews, as appropriate; implement and maintain processes required to support the business, in relation to product samples, consignment stock and returns to ensure compliance in accordance with Bard policies and procedures.
• Be the direct contact for the Spanish and Portuguese Competent Authorities and manage the relationship with them and deal with any specific queries relating to post-market regulatory and quality activities.
• As necessary, and in collaboration with clinical, marketing and sales departments, support tender applications as well as reimbursement activities and reimbursement requests for applicable product categories.
• Approve all locally generated promotional and advertising material to ensure compliance with national laws, Bard policy and procedures.
• Prepare documentation required in relation to any planned clinical investigations or post-market registries in Spain or Portugal.
• Participate in local working groups, including monitoring and communication of regulatory developments and changes in requirements to Divisional RA/QA Leadership.
• Ensure compliance with regulatory and quality requirements relating to service and repair for any Bard capital equipment placed on the market.
• Execute regulatory and quality requirements in accordance with Bard procedures covering the Item Master creation and International Regulatory Release (IRR) processes.
• Manage compliance with applicable requirements relating to Environmental Health and Safety (EHS) requirements (WEEE Directive/Batteries Directive/Packaging and Packaging Waste Directive).
• Oversee regulatory and quality activities needed to meet local Regulatory Agency requirements relating to post-market clinical investigations, evaluations or registries; provide notifications and reports to the local Regulatory Agency where required.
• Manage any local Regulatory Authority inspections and ensure appropriate engagement with local, regional, Divisional and Corporate leadership.
• Generate and provide metrics, reports and assistance to the General Manager, Iberia and Vice President Quality & Regulatory Affairs EMEA
• Liaise with internal and external customers as required, including local distributors, Agents and Non Bard OEM Suppliers.
• Provide training to local staff as required, ensuring Bard remains in compliance with established quality and regulatory requirements.
QUALIFICATIONS REQUIRED
EDUCATION & EXPERIENCE
The ideal candidate will likely have a scientific degree, and will have 5 or more years of experience working in a medical device/pharma/pharmacy environment with knowledge of CE marking and local Competent Authority requirements.
Key competencies the candidate will demonstrate:
· Good working knowledge of Quality Management System requirements, in particular ISO 13485 and ISO 9001.
· In-depth understanding of post-market surveillance requirements and the role of the EC Authorised Representative under the Medical Devices Directive, 93/42/EEC.
· Strong relationship building skills; demonstrated leadership coupled with the ability to work well with people at all levels and in all functions of the organization as well as with external regulatory agencies.
· Good analytical skills; attention to detail and ability to manage multiple tasks and priorities at the same time.
· Excellent communications, technical and presentation skills.
· Computer skills (Advanced with Microsoft Excel, Word, Outlook and PowerPoint).
· Fluency in Spanish; ability to read and speak English; working knowledge of Portuguese.
PROFILE
Customer Service Skills
Has the energy and ability to work with the customer service. Exhibits courage and curiosity. Demonstrated track record of success. Shows hunger to learn and keep up to date. Communicates clearly and fluently.
Results Orientation
Passion to win, is a self starter and has a sense of urgency to achieve results. Competitive and works hard.
Empathy
Listens to customers (internal or external) to find out their needs and objections.
Trust and Respect
Operates with integrity, openness, honesty and ethics to build long term relationships with customers. Establishes trust with customers. Positive attitude and a team player.
Planning and Accountability
Sees objectives through to the end and delivers against plans. Delivers on commitments.
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Job Role: / Regulatory Affairs & Quality ManagerGeographical Remit: / Spain & Portugal (Iberia)
Reports To: / Vice-President Quality & Regulatory Affairs, EMEA
Reviewed By: / Bill David
Additional Information / The location base for this role would be Barcelona.