Merck Senior Specialist, GRACS Devices & Digital Health in Washington, District Of Columbia
Our Regulatory Affairs team drives new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.
Under the direction and guidance of the DDH leadership and their manager the incumbent will assist in driving the overarching strategy for all Medical Device Modalities including, but not limited to: Combination Products (MDCPs), device constituents, in vitro diagnostics (IVD), and digital health in partnership with the Global Regulatory Leads (GRLs), Chemistry, Manufacturing and Control (CMC) scientists, Pharmacovigilance (PV), Global Labeling (GL), and various other functions. The incumbent will partner with the Clinical Safety and Risk Management (CSRM) physicians and PV group SMEs to ensure the clinical aspects needed to support filings are planned and executed for registrations and development of new business processes while maintaining regulatory and safety compliance.
The incumbent will support the development of new processes and establishment of internal guidance/policy for GRACS that enables timely and accurate advice to Global Regulatory Teams to ensure adherence to evolving Medical Device regulations globally.
Primary Responsibilities include:
Support the assessment, communication, and implementation of the emerging regulatory landscape and drive cross functional implementation of existing and new requirements across the GRACS functional areas and Global Regulatory Teams (GRTs) for all Medical Device Modalities across the company portfolio.
Provide support to assigned GRTs with responsibility to bring broad-based, cross-GRACS perspective on MDCP and digital health aspects impacting product development and share best practices for teams to incorporate into their regulatory strategies.
Participate and support as appropriate, operational processes and systems to fully incorporate MDCP, diagnostics, and digital health into the company across the broad product portfolio. Assist with building and managing new processes for facilitation and support of key initiatives.
Ensure close collaboration with cross-functional / cross-divisional teams (Manufacturing, Commercial, IT) to align on and incorporate regulatory requirements into strategies for MDCPs, device constituents, and digital health to ensure successful product registrations.
Support the development of best practice guidances for regulatory deliverables of MDCPs, diagnostics, and digital health in support of the therapeutically aligned development teams.
- Required: B.S. in a biological, engineering, chemistry, or related field such as regulatory affairs or quality assurance
Required Experience and Skills:
Ability to lead, influence and work effectively in a matrix organization.
Assist with establishing clear goals and assigning responsibility in a team setting
Effective team facilitation with ability to thrive in collaborative team environments
Knowledge of global regulatory requirements and the emerging regulatory landscape for MDCPs, digital health, pharmaceuticals, and vaccines for both new product development for initial registration and maintenance of registrations.
Comprehensive awareness of digital health technologies and its application to MDCP, pharmaceutical, and biologic development and marketed products.
Knowledge of Quality Assurance items such as quality management systems, ISO standards, and compliance.
At least two (2) years of relevant experience, including, but not limited to: Regulatory Affairs, Quality Assurance, Pharmacovigilance, scientific Research & Development, manufacturing, or related fields.
Preferred Experience, Education & Skills:
- Advanced degree (M.S., MBA, Ph.D., PharmD), RAC, ASQ, PMP, ISO certifications
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEOC GINA Supplement
OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Flex Time, Remote Work
Valid Driving License:
Number of Openings:
Requisition ID: R128341
- Merck Jobs