Job Description
The Global Regulatory Affairs and Clinical Safety (GRACS) DDH team assists in bringing 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 through a highly regulated industry.
Position Overview:
Under the guiding direction of the Executive Director and/or Director, Device and Digital Health, the incumbent will contribute to the overarching strategy for product-specific medical device and combination products (MDCPs), device constituents, digital health solutions (DHSs), and In-vitro diagnostics (IVDs) in partnership with the GRACS Global Regulatory Leads (GRL), Quality & Compliance, Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance (PV), Global Labeling (GL), and various other functional areas. The incumbent will partner with the Clinical Safety and Risk Management (CSRM) physicians and PV group, and MDCP SMEs to ensure the clinical aspects needed to support MDCP filings are planned and executed to support registration and/or maintenance of registrations.
The incumbent will assist in developing new processes and establish internal guidance/policy for Global Regulatory Affairs and Clinical Safety (GRACS) that enables timely and accurate advice to Global Regulatory Teams (GRTs) to ensure adherence to the evolving MDCP/DHS regulations globally. The Associate Director will provide support for cross-functional collaboration through the enterprise by working closely with Device Development, Clinical Development, Pharmacovigilance, Manufacturing, Policy, IT, and other areas to ensure successful execution of our product programs while maintaining regulatory and safety compliance.
Primary Responsibilities:
-
Support the communication and assessment of the emerging regulatory landscape and drive cross-functional implementation of existing and new requirements across the affected Global Regulatory Affairs and Clinical Safety (GRACS) functional areas for MDCP/DHSs.
-
Build and cultivate strong working relationships with key internal and external stakeholders.
-
Develop and deliver global regulatory MDCP/DHS/Diagnostic intelligence to identify upcoming regulations and pending changes that could impact products with direct engagement with relevant GRTs across the company portfolio.
-
Provide support to assigned products with the responsibility to bring broad-based cross-Global Regulatory Affairs and Clinical Safety (GRACS) perspective on MDCP/DHS/Diagnostic aspects impacting product development and share leading practices for teams to incorporate into their regulatory strategies.
-
Participate and support, as appropriate, initiatives that establish operational processes and systems to fully incorporate MDCP/DHS/Diagnostics into the company way of working across the broad product portfolio. Build and manage new processes for facilitating resources to support activities and key initiatives.
-
Ensure close collaboration with cross-functional and cross-divisional teams (Research Laboratories, Manufacturing, Commercial, IT, etc.) to align on and incorporate regulatory requirements into strategies for devices, device constituents of combination products, DHSs, and diagnostics to ensure successful product registrations.
-
Support the development of best practice guidance for regulatory deliverables for digital health, medical devices, combination products, and diagnostics to support the therapeutically aligned development teams.
-
Management of direct reports and/or contractors as assigned
-
Supports internal and external partners to ensure global regulatory risks are identified, communicated, and properly addressed.
Education:
-
Minimum: Bachelor’s Degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field
-
Preferred: Graduate degree (Ph.D., PharmD, MS, MBA) in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field
-
Preferred: RAPS RAC, ASQ Quality, or Scrum certifications
Required Experience and Skills:
-
Minimum of five (5) years of relevant experience in one or more of the following areas: Regulatory Affairs, Quality Assurance, Clinical/Medical Affairs, Pharmacovigilance, Medical Devices, Pharmaceuticals, Biologics, Research & Development, Manufacturing, or related fields.
-
Knowledgeable in global regulatory requirements and the emerging landscape for MDCP, DHS, and Diagnostic products for both new product development for initial registration, support of current registrations, and post-market compliance activities.
-
Relevant awareness of digital health technologies and its application to medical devices and combination products, pharmaceuticals development, and marketed biopharmaceutical products.
-
Problem solving skills to act logically and think outside the box
-
Capacity to work under pressure and with timelines, individually and within a team
-
Familiarity/Experience with Microsoft product suite
-
Project management and/or meeting facilitation skills
-
Preferred:
-
Direct personnel management experience, including mentoring, performance evaluations, and disseminating direct report responsibilities.
-
Professional communication and writing skills through venues such as, but not limited to, external speaking engagements and peer-reviewed publications.
Residents of Colorado
Click here to request this role’s pay range.
#IND3
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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Invent. Impact. Inspire.
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
Current Contingent Workers apply HERE
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 if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Flex Time, Remote Work
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R116926
Source: Indeed.com
Click Here To Apply
