Senior Regulatory Affairs Manager, Business Development - Remote
Olympus Medical Systems
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.
The Senior Business Development Regulatory Affairs Manager will report to the Business Development RA Director and is responsible to help drive strategic and tactical functional support for business development projects. This important role will be a key partner to the global Business Development core-team to ensure the RA function’s perspective, expertise, critical-thinking is embedded throughout an acquisition and integration efforts.
- Support Business Development projects as the global RA representative between RA functional teams, BD core-team, and cross-functional partners;
- Responsible for supporting and researching in-depth analysis of Medical Device and other relevant regulations as it pertains to the business development project;
- Understand and provide insight of a potential acquiring company’s (Target) product portfolio, regulatory compliance risks/violations, global market footprint, etc.;
- Drive initial drafts of a global regulatory plan that aligns with the BD Commercial team’s priorities;
- Collaborate with BD cross-functional leads to provide regulatory insight and/or complete any deliverables;
- Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting RA due diligence, integration strategy/planning activities, and integration execution against best practices;
- Provide recommendations to BD core-team and/or BD RA Director regarding all deliverables and required milestones;
- Support the Tool & Process Development and Continuous Improvement project by creating or improving RA tools, standard operating processes, playbooks, and lessons learned documentations;
- Help develop a clear integration plan, agreed to by BD, BD RA Director and applicable RA senior leaders;
- Understand resource planning and intercompany RA skills / expertise to drive resource recommendations;
- Help maintain an up-to-date view of all projects in the business development pipeline to be communicated to RA senior leaders;
- Coordinate with global and regional regulatory teams as applicable;
- Identify regulatory issues, concerns, watchouts associated with a Target’s regulatory technical documentation and licenses;
- Build and maintain a network of resources in all regions, across all businesses and divisions;
- Support efforts for RA functional and regional alignment;
- Help to on-board RA Integration leader to ensure smooth transition post deal close and into first 100 days of integration activities;
- Other BD project related tasks and deliverables as determined by the BD core-team and/or BD RA Director.
- Bachelor’s degree required.
- Minimum 10 years’ experience in regulatory affairs and medical device industry
- Strong USA FDA and EU MDR regulatory knowledge and/or submission experience
- Familiar with clinical requirements to support global, regulatory approvals
- Understanding of DMR, DHR, and DHF and the required documentation
- Strong excel, PPT and Smartsheet skills
- Excellent written and oral communication skills
- Ability to present clear messaging across all levels of an organization, including senior leadership
Why join Olympus?
Here, people matter—our health, our happiness, and our lives.
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $129,404.00 - $181,166.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||