Post Market Surveillance Manager
Job no: 608341
Work type: Permanent
Categories: Engineering, Quality & Regulatory, Western Europe, Individual Contributor
Cochlear’s global mission is to help people hear and be heard. Cochlear BAS is the division of Cochlear that designs and manufactures the world’s leading bone anchored solutions. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Situated in Mölnlycke, 10 minutes from the city centre of Gothenburg, Sweden, the head office employs approximately 200 people whose responsibilities include research, product design and development, marketing, quality and regulatory, manufacturing, distribution and administration for all the Baha® and Vistafix® products. Cochlear Bone Anchored Solutions AB offers you a modern environment in which you can work with passionate professionals to apply your specialist expertise and skills to bring the most advanced technologies to the market.
We Offer Challenging Work with Real Meaning
The work we do at Cochlear helps people with hearing loss to connect to others and live full lives. Whether you are involved in designing devices, manufacturing quality products, providing services to customers or supporting business processes, the work at Cochlear is stimulating for your mind and emotionally fulfilling and worthwhile.
We are recruiting for a Post Market Surveillance Manager in our Quality & Regulatory department, reporting to the Quality & after Market Manager. This is a newly created role as we are expanding our team.
In this role you will be responsible for managing a team which are focussed on complaints handling and also post market surveillance. To be successful in this role you will ensure follow-up on safety and efficacy of the products development at Cochlear CBAS. This role will also see you:
- Develop Post Market Surveillance Plans and assure that these plans are put into action
- Take responsibility for gathering and analysis of relevant data and documentation and reporting of the results
- Responsible for the effectiveness for complaint handling within Cochlear CBAS. This includes the responsibility for the development or procedures for complaint handling, responsibility for the initiation of non-conformities or CAPA requests based on any possible issues identified in complaints
- Responsible for analysis of Warranty and Repair data to identify drivers for cost of customer satisfaction
- Demonstrate active involvement in the implementation and improvement of relevant quality procedures
- Attract, develop and retain the best team to deliver Cochlear’s current and future business objectives
- Interact with the Global and Regional Post Market Surveillance teams to ensure alignment and collaboration
- Review and continuously improvement the complaints and Post Market Surveillance process
What makes this role unique is:
- Leading a team of skilled Complaints specialists and Post Market Surveillance Engineers
- Responsibility for maintaining intelligence of the performance of CBAS products
- Responsibility for effective and compliant customer complaints handling
- Working cross-functionally within CBAS and Global Cochlear.
- Learning about medical device industry regulations and quality standards.
- Learning and growing in the role as you take on new challenges.
You Bring Your Skills and Experience
As we grow the Acoustics business, we are looking for people with highly specialised skills and capabilities who share our passion for delivering quality hearing solutions to our customers.
As a regulated company, Cochlear has a responsibility to hire people with the right skills and qualifications to do the work. To add value to Cochlear in this role you'll be able to demonstrate the following skills and experience:
- Excellent leadership skills to enable development of the Post Market Surveillance team
- Participate in development projects to assure that effective Post Market Surveillance plans are established
- Assure that product safety and efficacy data is collected, analysed and documented.
- Report Post Market intelligence to internal stakeholders
- Escalate findings from Post Market Surveillance to Non-Conformities or CAPAs when necessary.
- Identify, initiate and drive activities to enhance customer satisfaction related to CBAS products and services
- Assure that procedures for Complaints handling are effective and compliant
- Assure that procedures for Post Market Surveillance are effective and compliant with standards
- Assure that procedures for Post Market Surveillance are followed
We expect you to have:
- University education in engineering or other relevant area
- A minimum of 5 years’ experience from the pharmaceutical, biotech or medical device industry
- Solid experience of Post Market Surveillance and Market Intelligence in pharmaceutical, biotech or medical device industry
- Good individual, team, cross-functional and cross-regional communications skills.
- Ability to influence others through credible actions and effective negotiation
- An analytical mindset, sound judgment and decision making skills.
- Knowledge of statistical and analytical techniques.
- Thorough knowledge of the Office applications and standard statistical packages.
- Excellent presentation skills
- Fluent in spoken and written English
We think you are:
- Skilled at building trust, strengthening relationships and communicating openly
- Inspiring and implementing new ways of thinking and operating
- Pragmatic and have a solution-oriented personality
- Able to solve problems and collaborate to get work done that delivers benefits for Cochlear’s customers.
- Having a responsible attitude to working safely and building the safety culture.
- Willing to demonstrate a commitment to lifelong learning and development
Is Cochlear right for you?
Like us, you might be strongly attracted to Cochlear’s mission to help people to hear.
- Passionate about our Mission to help people hear and be heard.
- Growing globally and building business processes and governance maturity.
- Careful, prudent and professional about the way we manage our business in a regulated industry.
- Highly collaborative with a complex global stakeholder environment where you influence with facts and data.
- Strongly focused on delivering quality for our customers.
- Constantly striving for continuous improvement.
We Reward Performance and Offer Flexible Benefits
We reward and recognise people who perform their work in a way that is aligned to Cochlear’s mission and values and that contributes to Cochlear’s growth. To help us attract and retain people with the right skills we aim to pay competitively in the health science and technology markets. To encourage people to achieve outcomes aligned to Cochlear’s strategy we link the incentives we offer to both the financial performance of the company and individual achievement.
Take the first step towards a career with Cochlear. A career you can be proud of. Apply online today.
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