Senior Manager Medical Affairs (mfd)

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Baxter Medical Systemsenables excellence in surgical procedures using modern medical technology. Our products help care teams achieve outstanding results in emergency and critical care. Digital systems are automated to allow for surgical staff and multidisciplinary care teams to work efficiently and devices are needed to navigate processes increase user convenience and improve patient safety.

We are currently searching a Senior Manager Medical Affairs (m/f/d) based in Munich.

Summary

The Global Manager Sr. Medical Affairs - HST (Manager MA HST) will provide both clinical development and launch expertise as well as technical knowledge to assigned product line(s) of appropriate HST division. This person is responsible for aligning their team with HST Medical Affairs and other pertinent departments. Critical to this role is global and regional clinical knowledge of surgical medical devices environments of care and data use as well as the ability to offer guidance for product development support. The Global Manager MA HST is accountable for establishing nurturing and maintaining strong collaborative relationship with critical WWM colleagues (such as Clinical Research HEOR/RWE Global Patient Safety and WWM Strategy and Delivery) as well as cross-function partners (such as R&D RA Quality Marketing) to enable a highly efficient and effective working environment.

ESSENTIAL DUTIES and RESPONSIBILITIES:

• Serve as the medical device subject matter expert to both internal and external customers for product development risk assessment training implementation literature reviews complaints safety signals field action voice of the customer and voice of the business.

• Devise novel approaches to address clinical and technical problems in clinical practice through development and modification of related medical devices.

• Provide accurate balanced and timely clinical expertise to functional areas such as clinical development R&D marketing manufacturing quality assurance regulatory affairs and legal based on objective evidence clinical experience and voice of the customer.

• Assimilate voice of customer and clinical experience for design input with new product development and product lifecycle management.

• Provide clinical expertise for creation and development of risk assessments and quality standards for product design history files.

• Indepth knowledge of EMDUR clinical documentation requirements including but not limited to safety and performance criteria intended use etc.

• Develop and deliver relevant medical device training programs (e.g. written verbal and eLearning) that support product implementation training and marketing efforts.

• Train internal customers on product application disease states and regional differences as required.

• Support product implementation process creation maintenance and controlled launch planning when applicable.

• Maintain familiarity of published literature as objective evidence for clinical trends and therapies related to impact on product lines.

• Understands and adheres to internal and external complaint and adverse events handling requirements including standard response communications.

• Supports legal and regulatory and quality requirements related to R&D and product lifecycle management.

• Maintains compliance with current standard operating procedures.

• Assumes other duties and responsibilities as assigned by manager/supervisor.

• Clinical core competency for related products.

• Technical core competency for related products.

• Legal and regulatory core competency for related products.

KEY QUALIFICATIONS:

• Excellent written oral communication and organizational skills.

• Effective and competent presentation and teaching skills.

• Self-motivated independent mulit-tasking team-oriented individual with exceptional follow through. - Industry experience preferred

• Degree in related clinical discipline or equivalent required

• Experienced and skilled Nurse/Practitioner with significant surgical device background required.

• Active license or regional equivalent in good standing required.

• Minimum 5 years of related Surgical experience required.

• Experience with surgical tables lights table accessories and booms systems along with healthcare information technology implementation and training preferred.

• Knowledge of Baxter products and competitive products preferred. - Industry experience preferred

• Indepth knowledge of class I and II device registration including EMDUR and FDA clinical document SME (CEP/CER/PMS)

EDUCATION & EXPERIENCES:

• Bachelors degree or advanced degree (BSN MSN DNP RN) in Health or Science field preferred

• Minimum 5 years of relevant Industry experience required

OTHER REQUIREMENTS:

• 3 day a week in office two days remote/Munich and/or Saalfeld Germany

• Travel required domestic and internationally may be up to 50%

• Fluent in German and English languages

What we offer you

As an internationally active company we offer you professional training opportunities and fair remuneration with above-average social benefits a company pension scheme a share plan for employees 30 days vacation plus special leave and additional insurance is a matter of course for us.

For further information please reach out to Mr Sebastian Lange via E-Mail:

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion Baxter may decide to adjust suspend or discontinue as business needs change.

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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