Lediga jobb Cochlear Bone Anchored Solutions AB i Göteborg

Make a difference with Cochlear.

Cochlear is the global leader in implantable hearing solutions. In this role, you'll manage day?to?day accounting processes across our Nordic entities (Sweden, Finland, Norway, and Denmark), ensuring accurate reporting, strong financial control, and great service to our internal and external stakeholders. You'll work closely with a Senior Accountant while partnering across Order?to?Cash and Purchase?to?Pay processes to drive performance and continuous improvement.



What you'll do

Accounts Receivable (AR)

- Achieve debt reduction and cash collection targets across assigned countries

- Accurately and timely process incoming customer payments and maintain customer master data

- Produce AR reports and insights for stakeholders (e.g., DSO, aging, cash collections)

- Ensure OTC processes comply with company policies and relevant legislation

- Lead/participate in continuous improvement initiatives to enhance AR efficiency

Accounts Payable (AP)

- Process supplier invoices and payments in line with agreed terms

- Maintain supplier master data and controls

- Ensure P2P processes align with policies and legal requirements

- Identify and implement AP efficiency improvements

Accounting & Financial Reporting

- Prepare monthly Income Statement and Balance Sheet in line with local GAAP and Cochlear group standards (IFRS)

- Ensure accurate accruals, prepayments, and restatements transactions

- Calculate, review, and post transfer pricing and tax accruals

- Prepare annual financial statements, VAT returns, and other statutory filings for Nordic entities

Financial Control & Audit

- Perform monthly account reconciliations and maintain effective financial controls

- Ensure robust controls over payables, expense processing, capex, and intercompany

- Support internal/external audits, including year?end

Business Partnering

- Provide reporting and analytical support that helps stakeholders make better decisions


About you

- 3+ years' experience in accounting/finance within a multinational environment

- Knowledge of local GAAP (Nordics) and IFRS

- Hands?on experience with AR and AP processes

- Proficient in ERP (e.g., SAP or Oracle) and very strong Excel skills

- Degree in Accounting/Finance

- Fluent in English (spoken and written); fluency in a Nordic language is an advantage

- Proactive, structured, collaborative, with a continuous improvement mindset and a natural service orientation



What we offer

- Purpose-driven work that changes lives

- Learning and development with real career pathways

- Inclusive, collaborative culture

- Hybrid work with international exposure

- Competitive benefits package

How to apply: Submit your CV (and brief cover note) via [Company Careers Page/ATS link].

Inclusion: We welcome applications from all qualified candidates and are committed to an inclusive workplace. Visa mindre

Job Overview: We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our team. This role is crucial in providing regulatory support throughout the lifecycle of Cochlear products. The Senior Regulatory Affairs Specialist will work closely with R&D cross-functional project teams, sustaining engineering, and manufacturing groups to ensure compliance with regulatory requirements.



Key Responsibilities:


* Regulatory Strategy and Planning: Support project teams with regulatory and standards compliance advice through product development. Define documentation needs and ensure they are delivered to quality and timeline requirements. Develop regulatory strategies in collaboration with regional regulatory teams, to support business plans for products or projects. Participate in strategic regulatory and continuous improvement projects as required.

* Regulatory Submissions and Related Activities: Prepare and manage the submission process to gain new or modified product approvals and maintain product licenses. Adapt or create technical dossiers for regional market submissions and coordinate support for regional subsidiaries, offices, and distributors. Ensure timely regulatory assessments of sustaining changes, including submissions or the necessary documentation of them (e.g. Letter to File).

* Cross-Functional Regulatory Direction: Evaluate labeling and manufacturing changes and promotional material for regulatory impact. Provide regulatory direction to the business and inform the organization about new or changing national regulations/trends and propose implementation plans. Drive the implementation of better regulatory practices and processes.



Qualifications:


* Proven experience in regulatory affairs, including management, compilation, submission, and maintenance of regulatory filings.

* Strong skills in influencing in a matrix team environment and managing stakeholders at all levels within the business.

* Ability to make judgments and provide advice that balances business interests and regulatory risk.

* Excellent review, report writing and documentation skills.

* Knowledge of global regulatory requirements and regulations for medical devices, with an emphasis on MDR.



Certifications:


* Regulatory Affairs Certification (RAC) is highly desirable.



Education:


* Minimum Bachelor's degree in engineering, legal, scientific, or healthcare; or 3+ years' experience in software or product development, quality, and/or regulatory affairs.



Languages:


* English - Advanced/Fluent.



Work Experience:


* 3+ years' experience in regulatory affairs, including a track record of management, compilation, submission, and maintenance of regulatory filings.

* 3+ years' experience in medical devices product or software development (SaMD).

* Ideally worked in a global matrix organization including manufacturing and logistics. Visa mindre

The Opportunity

Cochlear is thrilled to announce a newly created Director of Clinical Portfolio Strategy role in our Gotenberg office-focusing on the Acoustics Portfolio, this role is specifically tasked with oversight of Acoustics products, ensuring all evidence needs relating to claims are addressed and managing the Gothenburg-based Clinical Audiologists to provide appropriate support and subject matter expertise to product design and validation. If you're passionate about transforming lives through innovative hearing solutions and thrive in a dynamic environment, we want to hear from you!



In this pivotal role, you will lead a talented team of Clinical Development Managers and Clinical Research Audiologists. Reporting to the Director of Clinical Design and Strategies, you will shape our clinical evidence strategies and ensure that our product portfolios meet the highest standards of innovation and efficacy.



Responsibilities include:



· Lead a High-Performing Team: Inspire and manage a talented team to develop and implement innovative clinical evidence strategies, study designs, and documentation for Cochlear's diverse product portfolios.



· Drive Clinical Expertise: Leverage your clinical and scientific knowledge to identify unmet needs, shaping commercial solutions and strategic initiatives that make a real impact.



· Collaborate for Success: Partner closely with commercial and R&D teams to ensure our evidence strategies align with business objectives and regulatory standards, optimising product design and market access.



· Innovate with Emerging Technologies: Play a crucial role in integrating cutting-edge technologies that enhance candidate access to hearing care and elevate patient experiences.



· Steer Clinical Evidence Strategy: Take charge of the short- to mid-term Clinical Evidence Strategy and Plan (CESP) for the Product and Services Plan (PSP), driving excellence across our portfolio.



· Foster a Culture of Collaboration: Build and nurture strong partnerships across the organisation, promoting cross-functional teamwork to achieve common goals.



· Develop Comprehensive Strategies: Oversee the creation of a robust evidence strategy that aligns with business objectives, ensuring a clear pathway to success for the portfolio area.



· Drive Portfolio Planning: Lead the strategic planning and execution of the overall portfolio, ensuring seamless integration of all clinical initiatives.



· Communicate with Clarity: Articulate clinical plans and strategies effectively to stakeholders, fostering alignment and understanding throughout the organisation





What makes this opportunity unique?



· Cross-Organisational Exposure: This role offers invaluable exposure to various facets of the organisation, bridging commercial needs with product features and aligning them within a strategic framework. You'll gain insights into the medium- to long-term vision of our initiatives.



· Strategic Influence: Engage with strategy at multiple levels, connecting with key stakeholders across departments. Your contributions will be vital in shaping the overall direction and success of projects.



· Central Role in Project Development: Act as a critical link between all projects and the clinical team, ensuring that insights and strategies flow seamlessly and that clinical considerations are integrated into product development.



· Visibility and Impact: Enjoy high visibility within the organisation, allowing you to make a meaningful impact on our product offerings and drive innovation in hearing care.



· Collaborative Environment: Work closely with diverse teams, enhancing your network and fostering collaborative relationships that are essential for strategic execution.





About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:



· Educational Background: You hold a Bachelor's degree or higher in a scientific or healthcare discipline. A PhD or tertiary qualification in Audiology, or experience in a hearing care setting or industry, is highly desirable.



· Clinical Expertise: You bring approximately 10 years of experience in clinical research within the medical device sector or a relevant field. Your background includes developing clinical strategies, study design, and reporting.



· Leadership Experience: You have demonstrated ability in managing people, leading globally dispersed clinical research teams in pharmaceuticals or medical devices. Your experience in a commercial environment enhances your ability to connect clinical strategies with business objectives.



· Regulatory Knowledge: You possess a thorough understanding of the international device development process, including strong familiarity with Medical Device and Clinical regulations such as ISO 13485, ISO 14155, FDA 21 CFR, and MDR. You have experience interacting with regulatory bodies like the FDA, TUV Sud, or TGA, leading to successful product approvals.



· Communication Skills: You are a clear and effective communicator, with well-developed report and technical writing skills. You are comfortable presenting complex information to various stakeholders. Visa mindre

Are you a seasoned professional in Regulatory Affairs looking to make a significant impact on a global scale? Cochlear Limited, a leader in implant, sound processor, and acoustics products, is seeking a dynamic Director of Regulatory Affairs. In this pivotal role, you will lead our CBAS Regulatory team based in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide. Your leadership will drive cross-functional partnerships and alignments, contributing to our mission of transforming lives.



Key Responsibilities:

Strategic Leadership:


* Shape and execute global regulatory strategies.

* Mentor and guide your team to provide critical regulatory insights for Cochlear's Product Innovation Process (PIP).

* Present strategic recommendations to CBAS leaders and Regional Regulatory teams.

* Oversee multiple high-priority projects, ensuring successful outcomes.

* Forge strong relationships and negotiate with external regulatory bodies.

* Communicate effectively with all stakeholders to foster teamwork and alignment.

* Deliver impactful business and technical briefings to key stakeholders.


Operational Excellence:


* Develop and optimize systems for tracking regulatory submissions and commitments.

* Lead the team in managing change controls and submission requirements.


Regulatory Compliance:


* Serve as the appointed "Person Responsible for Regulatory Compliance" (PRRC).

* Review and approve labelling materials.

* Address European regulatory requirements for recalls and adverse event filings.

* Participate in regulatory audits and inspections.

* Maintain QMS procedures related to Regulatory Affairs.


Team Development:


* Attract, develop, and retain top talent to achieve Cochlear's business objectives.

* Provide regular feedback and coaching to foster growth and success.

* Champion workplace health and safety initiatives.



Key Requirements:

Minimum:


* Bachelor's degree in a related field with extensive experience in Regulatory Affairs.

* Knowledge of at least two medical device jurisdictions (e.g., FDA, TGA, EU MDR).

* Proven experience in healthcare, regulatory affairs, and medical devices.

* Expertise in financial mechanisms and budget management.

* Demonstrated ability to lead teams and collaborate with People and Culture.

* Exceptional attention to detail and proficiency in English.

* Ability to thrive in a fast-paced, dynamic environment.


Ideal:


* Master's degree in a related field.

* Strong negotiation and influencing skills for optimal commercial outcomes.

* RAPs certification. Visa mindre